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Job Description About the company Deep Foods is one of the leading manufacturers of Indian foods. Since 1977, it has been tantalizing the taste buds of Indian food lovers. Using authentic recipes, Deep Foods offers delicious snacks, frozen meals, ice creams and other specialties. Position summary The FSVP/Regulatory Compliance Specialist supports and maintains the company’s Foreign Supplier Verification Program (FSVP) and import compliance activities for a diverse portfolio including RTE frozen foods, spices, snacks, ingredients, and finished goods. This role ensures imported foods meet FDA/FSMA requirements through supplier documentation management, verification activity tracking, risk-based assessments, and inspection-ready recordkeeping across multiple suppliers, products, and distribution locations. Department: Quality / Regulatory Reports to: Director of Quality/Regulatory Manager Location: Union, NJ Key responsibilities Standard Hours: 10:00 AM – 6:00 PM but flexible. This is not a remote position, and requires international travel to support supplier audits, facility visits, and verification activities. · Maintain FSVP files for each foreign supplier, ensuring completeness and inspection readiness. · Support the FSVP Qualified Individual (QI) by preparing documentation for hazard evaluations and supplier verification plans, and tracking completion to schedule. · Collect, review, and organize supplier compliance documents, verification activities, and file results in the FSVP system. · Support supplier approval/monitoring: maintain approved supplier list status, performance tracking, and escalation of issues. · Assist with import entry documentation coordination with customs brokers/forwarders: ensure required documents are available, consistent, and retrievable. · Initiate and document corrective actions for supplier nonconformances related to imported materials (e.g., import alerts, refusals), including follow-up and closure support. · Participate in inspection readiness: rapid retrieval of FSVP/import records for FDA inquiries/inspections; support responses and internal action tracking. · Work cross-functionally with QA, Procurement, Logistics, and Operations to align supplier compliance requirements with purchasing and receiving practices across distribution warehouses and the manufacturing facility. Qualifications Required · Bachelor’s degree in Food Science, Microbiology, Chemistry, Regulatory Affairs, or related (or equivalent experience). · 3–5 years in food industry QA/regulatory/supplier compliance, with exposure to imports and supplier verification. · Experience with RTE frozen foods, spices, and/or snacks. · Knowledge of FSMA/FSVP concepts. · Knowledge of relevant food safety legislation, GFSI audits, HACCP · Strong documentation control skills; comfortable with audits/inspection readiness. · Strong communication and follow-up skills with suppliers and internal teams. · FSVP Qualified Individual preferred. \nCompany Description Deep Foods is a major food manufacturer based that specializes in prepared Indian foods and frozen food products. Since 1977, we have been dedicated to delivering high-quality products through innovation and a commitment to excellence. Our mission is to bring authentic Indian cuisine to consumers nationwide while maintaining the highest standards of quality and safety. Deep Foods is a major food manufacturer based that specializes in prepared Indian foods and frozen food products. Since 1977, we have been dedicated to delivering high-quality products through innovation and a commitment to excellence. Our mission is to bring authentic Indian cuisine to consumers nationwide while maintaining the highest standards of quality and safety.

1. POSITION SUMMARY Reporting directly to the Group Vice President (GVP) of Immunology Sales, this role serves as the GVP's strategic and operational right hand within the Immunology commercial organization at Celltrion USA (CUSA). The successful candidate will partner closely with locally hired field sales, marketing, market access, and cross-functional teams to translate the GVP's priorities into executable field-level actions across Celltrion's immunology portfolio (e.g., Zymfentra, Inflectra, and future launches). The position is created as a locally hired (non-expatriate) role to strengthen alignment between the U.S. commercial organization and Korea Headquarters. Bilingual Korean/English capability is a core requirement to enable real-time communication with HQ leadership, translate business materials between Korean and English, and serve as a cultural and linguistic bridge between the U.S. field organization and HQ. This is a hands-on, high-visibility role for a candidate who can operate strategically at the GVP level while also driving day-to-day execution with U.S. sales leaders and field representatives. 1. KEY ROLES AND RESPONSIBILITIES GVP Support & Immunology Business Strategy • Serve as chief of staff–style partner to the GVP of Immunology Sales, driving planning cycles, business reviews, leadership offsites, and executive communications., • Translate the GVP's strategic priorities into concrete operational plans for the Immunology field organization; track execution and flag risks proactively., • Prepare board-quality briefing materials, decks, and analyses for internal U.S. leadership and HQ (Incheon) reporting cadences., • Represent the GVP's office in cross-functional forums when delegated. Sales Strategy & Commercial Execution (Immunology) • Partner with Immunology sales leaders and locally hired field teams to design and execute national and regional sales plans for Zymfentra, Inflectra, and other assigned immunology assets., • Analyze territory-level performance, targeting, call activity, formulary wins, and payer/channel dynamics; recommend course corrections to the GVP., • Coordinate promotional priorities, KOL engagement plans, congress activities, and speaker programs with Marketing and Medical Affairs., • Support pricing, contracting, and account-level strategy discussions across buy-and-bill, specialty pharmacy, IDN, and GPO channels in partnership with Market Access. HQ Bridge & Bilingual Coordination • Serve as the primary bilingual interface between the U.S. Immunology commercial team and Celltrion HQ (Korea), including senior Korean expatriate leadership residing in the U.S., • Translate and localize key business documents, presentations, and reports between Korean and English; ensure nuance and intent are preserved in both directions., • Facilitate cross-time-zone meetings and follow-ups with HQ Sales, Global Marketing, and Supply Chain counterparts., • Escalate U.S. market insights to HQ and translate HQ guidance into actionable direction for the U.S. field organization. Cross-Functional Coordination • Act as a central point of contact for internal matters affecting Immunology commercial execution — supply, regulatory, medical, finance, legal, quality, and global teams., • Lead or facilitate working sessions to resolve product-, customer-, or channel-related issues in a timely manner., • Ensure decisions, action items, and commitments are documented and followed through. Financial & Performance Management • Partner with Finance and Commercial leadership to monitor Immunology revenue, demand, gross-to-net, inventory impact, and budget performance., • Prepare monthly and quarterly business updates, forecasts, and performance summaries for the GVP and HQ reporting., • Identify opportunities to improve sales execution, operational efficiency, and overall Immunology franchise contribution. 1. QUALIFICATIONS • Minimum 5–7 years of relevant experience in the pharmaceutical, biotechnology, or biosimilar industry, with meaningful exposure to U.S. commercial operations., • Experience in immunology, gastroenterology, rheumatology, dermatology, or biologics/biosimilars strongly preferred., • Working knowledge of U.S. commercial channels — buy-and-bill, specialty pharmacy, IDN, GPO, and Part B/Part D reimbursement dynamics., • Demonstrated ability to work as a strategic partner to senior executives (VP/SVP level) and to influence without direct authority across functions., • Strong analytical skills; ability to interpret sales, market, payer, and financial data and translate insights into recommended actions., • Excellent written and verbal communication, project management, and stakeholder management skills., • Comfortable operating in a fast-moving, matrixed, multinational environment. Language Requirement (Business Necessity) Bilingual proficiency in Korean and English (both verbal and written) is required for this role. 1. EDUCATION • Bachelor's degree required, preferably in Life Sciences, Business, Healthcare Administration, Public Health, or a related field., • MBA, MPH, or advanced life sciences degree is a plus. 1. CORE COMPETENCIES • Executive Partnership: Ability to operate as a trusted extension of the GVP, anticipate needs, and drive outcomes on their behalf., • Strategic + Operational Thinking: Ability to move fluidly between long-range strategy and week-to-week execution., • Cross-Cultural Bridging: Ability to navigate U.S. and Korean corporate cultures and communication styles with equal fluency., • Cross-Functional Leadership: Ability to influence, align, and mobilize teams across Sales, Marketing, Market Access, Medical, Finance, and HQ without direct authority., • Analytical Decision-Making: Ability to use data to identify trends, risks, and opportunities and translate them into clear recommendations., • Executive Communication Presence: Ability to present complex business information clearly and confidently to senior U.S. and Korean leadership. 1. WORKING CONDITIONS • Hybrid work model based out of Jersey City, NJ headquarters., • Domestic U.S. travel up to 30–40% for field ride-alongs, customer meetings, and internal offsites., • Occasional international travel to Celltrion HQ (Incheon, South Korea)., • Regular participation in early-morning or late-evening calls to accommodate Korea time zone., • Celltrion USA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Language requirements stated in this posting are established as bona fide business necessities.

This is a field-based and remote opportunity supporting a team. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 60-80% travel. The ED, Access & Reimbursement, RLT is responsible for co-creating field execution and pull through strategies based on the overarching business strategy and is ultimately accountable for delivering high, pre-defined business impact for the Novartis Pharmaceutical Corporation (NPC). The ED will advocate and motivate regions to deliver consistent acceleration of aligned business objectives and impact, while consistently demonstrating openness for courageous conversations and performance management of their direct reports to enable and bolster a culture-forward team mindset. • Attract, coach and retain team of high performing regional directors and access & reimbursement professionals., • Effectively translate pre-specified national strategy to a regional level to enable appropriate exquisite execution and pull through within team. Provide input to market access & patient support strategy team on materials, tools, and trainings required. Motivate each region to align on national strategy and key business impact metrics., • Partner closely with customer engagement and market access & patient support teams to ensure strong collaboration and coordination of field associate activities, business plans, and customer resolutions., • Integrate with Novartis leadership and collaborate across multi-functional teams (sales, marketing, market access, operations, training, legal, compliance, etc.) to ensure collaborative and compliant approach to support field success., • Facilitate a culture of collaboration and accountability through ongoing cadence discussions with field leaders, internal partners (NPS analytics, people & organization, commercial capabilities, Novartis patient support, marketing, customer engagement, commercial operations) to identify scalable business practices and to problem solve potential field barriers to effective and compliant execution., • Understand specifics of, and resolve questions associated with, practice and/or patient reimbursement to support on any issues with third party payers., • Education: Minimum of a bachelor's degree; advanced degree preferred (majors preferred: sciences, business, pharmacy, and healthcare), • Minimum of 10 years in reimbursement, contract strategy (if applicable), managed care, sales/marketing or related field. At least 5 years leading a regional or local team and managing and collaborating across multiple stakeholders, • Experience working with highly complex practices and/or health systems to establish access and acquisition pathways, • Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access., • Deep expertise and experience integrating manufacturer-sponsored patient support programs, • General knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail), • Experience with specialty products acquired through specialty pharmacy networks and through buy-and-bill process, including expertise in acquisition, billing and coding, claims processing, and reimbursement, • Possess a strong understanding of commercial payers, Medicare plans and state Medicaid in geographic region, • Proven track record building, and motivating teams. Past success in execution of launch strategies and plans, • Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license, • Complex/rare disease experience preferred (nuclear medicine, CAR-T, AAV gene therapy, etc.) Novartis Compensation Summary: The salary for this position is expected to range between $248,500 and $461,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Driving is an essential function of this role: meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com For field roles with a dedicated training period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Skills Desired: Business acumen, cross-functional collaboration, cross-functional leadership, employee development, health economics, health technology assessment (HTA), influencing skills, innovation, inspirational leadership, patient care, people management, process management, product launches, project management, public affairs, real world evidence (RWE), regulatory compliance, resource allocation, results-oriented, risk management, stakeholder engagement, stakeholder management, value propositions

The ideal location for this role is East Hanover, New Jersey site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager: US and European travel required (estimated 30-35% annually, up to 40% seasonally). Novartis is unable to offer relocation support: please only apply if accessible. Company will not sponsor visas for this position. Join Novartis at a moment where an inspired, curious, and unbossed medical leader can leave a lasting imprint on cardiovascular and metabolic carewhile shaping impact at scale. As Vice President, Medical Team Head for Cardiovascular and Metabolism, you will set the US medical vision for a multi?billion?dollar portfolio, translating breakthrough science into meaningful patient outcomes. Operating at the intersection of medical innovation, strategy, and external partnership, you will shape standards of care, advance access to innovation, and represent the voice of your therapeutic area at US and Global levels, both internally and externally. This role is built for a bold, collaborative leader energized by complexity, influence, and the opportunity to improve lives. • Set and lead the US medical strategy across marketed, pre?launch, and life cycle management indications., • Shape the healthcare landscape through strategic partnerships and senior?level regulatory engagement, including Food and Drug Administration interactions., • Advance patient access by partnering on health outcomes and real?world evidence to support reimbursement and clinical adoption., • Expand the portfolio by leading US medical input into business development and licensing and new product commercialization., • Drive enterprise impact through cross?functional leadership across Medical, Clinical Development, Global Medical Affairs, and Commercial teams., • Build and develop high?performing teams while modeling an inclusive, inspired, curious, and unbossed Novartis culture., • Bachelor's or equivalent 4-Year University Degree required; Doctorate?level degree in MD, DO, PharmD, or PhD in Health Sciences or related field required; Medical Degree (MD, DO) or equivalent preferred., • Twelve or more years of progressively senior experience in clinical development or medical affairs within the pharmaceutical, biotechnology, or academic institution/clinical practice., • More than five years of people management and team leadership experience, with a strong track record of developing senior medical talent is preferred., • Deep understanding of the United States healthcare landscape, including payer dynamics, access pathways, and evolving healthcare system trends., • Strong clinical research experience, including protocol development, clinical trial operations, and leading patient recruitment strategies., • Demonstrated expertise in health economics, outcomes research, and real?world evidence to support patient access, reimbursement, and value demonstration., • Demonstrated enterprise?level influence, with the ability to shape strategy, align senior stakeholders, and drive impact across US and Global organizations., • Cardiovascular and metabolic therapeutic area experience, with strong disease?state knowledge and clinical credibility., • Established relationships with medical experts and professional societies within the cardiovascular or metabolic landscape. The salary for this position is expected to range between $318,500 and $591,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Help shape the patient and caregiver experience in facioscapulohumeral muscular dystrophy (FSHD). As the Associate Director, Patient Marketing Strategy, you will develop and execute patient-focused marketing initiatives that support disease awareness, engagement, and launch readiness, helping translate patient, caregiver, and advocacy insights into meaningful educational and marketing programs. Working across Patient Services, Advocacy, Market Access, Medical Affairs, Customer Experience, and agency partners, you will play a key role in strengthening connections with the FSHD community, supporting treatment readiness, and building the capabilities and engagement infrastructure needed to support a successful launch and ongoing patient engagement. This position will be located in East Hanover, NJ or Cambridge, MA and will not have the ability to be located remotely. Please note that this role would not provide relocation, and only local candidates will be considered. This position will require up to 20% travel as defined by the business (domestic and/or international). • Partner with the Director, Marketing Strategy, to develop and execute an integrated patient and caregiver marketing strategy, including branded promotion, grounded in patient insights, behavioral science, advocacy partnerships, and launch-readiness priorities., • Develop patient content, unbranded and branded campaigns, educational resources, community programs, support tools, and digital experiences that are insight-led, compliant, inclusive, and aligned to brand and disease-state strategy., • Develop patient and caregiver disease-state education strategy to increase understanding of FSHD progression, diagnosis, genetic confirmation, care coordination, and the importance of staying connected to appropriate specialist care., • Lead patient journey mapping, segmentation, behavioral strategy, and patient/caregiver jobs-to-be-done to identify priority barriers, moments of influence, and activation opportunities across the FSHD journey., • Partner with advocacy organizations, patient communities, caregivers, and key community stakeholders to build trusted, compliant, and meaningful engagement that informs strategy and strengthens the FSHD ecosystem., • Build patient activation, retention, and engagement programs that support patient re-engagement, informed conversations with healthcare providers, specialist connection, and treatment-readiness behaviors., • Identify patient, caregiver, and system-level barriers to diagnosis, genetic confirmation, treatment adoption, access, and ongoing engagement; translate insights into clear action plans and measurable interventions., • Collaborate closely with Patient Services, Patient Advocacy, Market Access, Medical Affairs, Communications, Legal, Regulatory, Compliance, Customer Experience, Insights & Analytics, Field, and agency partners to ensure coordinated execution., • Define patient marketing priorities, budget needs, agency scope, launch milestones, KPIs, and optimization plans to measure belief shift, engagement, reactivation, diagnosis/genetic confirmation progress, and launch readiness., • Bachelor's degree in related field., • Minimum of 5 years of experience in commercial marketing with either rare disease, specialty, neurology, neuromuscular, genetic testing, or complex chronic condition patient marketing experience., • Minimum of 3 years of demonstrated experience of leveraging data, analytics, and customer insights to drive personalization at scale., • Strong cross-functional leadership and ability to collaborate effectively with various stakeholders and teams including Product, Communications, Legal, Regulatory, Compliance and Global., • Experience developing patient and caregiver disease-state education, unbranded and branded patient campaigns, support programs, or community engagement strategies., • Demonstrated experience partnering with patient advocacy organizations, patient communities, caregivers, and external stakeholders in a compliant, patient-centered way., • Experience with patient journey optimization, behavioral insight generation, segmentation, digital engagement, CRM, social/community listening, or omnichannel patient activation., • Pre-launch and launch experience, including market shaping, patient activation, treatment-readiness planning, and cross-functional launch execution., • Master of Science and/or MBA, • Multi-functional experience in pharmaceutical or healthcare Novartis Compensation Summary: The salary for this position is expected to range between $152,600 and $283,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Skills Desired Asset Management, Commercial Excellence, Cross-Functional Collaboration, Influencing Skills, Leadership, Operational Excellence, Product Lifecycle Management (PLM), Product Marketing, Stakeholder Engagement, Stakeholder Management

You are a seasoned regulatory affairs professional with strong hands-on experience through clinical regulatory affairs content and strategy, and navigating FDA and international regulatory frameworks. We are seeking an experienced Director, Regulatory Affairs to support and execute regulatory strate