Regulatory Affairs Associate
13 hours ago
Tampa
Regulatory Affairs Associate Company Overview Founded in 2017, Eton is an innovative pharmaceutical company focused on developing, acquiring, and commercializing high-potential therapies for the treatment of patients with rare diseases. We take pride in helping rare disease patients overcome unthinkable challenges to live up to their greatest potential. Eton currently has eleven commercial rare disease products: KHINDIVI®, INCRELEX®, ALKINDI SPRINKLE®, DESMODA™, GALZIN®, HEMANGEOL®, PKU GOLIKE®, IMPAVIDO®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: Amglidia®, ET-700, ET-800 and ZENEO® hydrocortisone autoinjector. Our location in Tampa, FL currently has an opportunity for a Regulatory Affairs Associate. Primary Job Function The Regulatory Affairs Associate will support day-to-day regulatory activities for Eton’s commercial and development-stage pharmaceutical products. This position will be responsible for assisting with regulatory labeling activities, preparation and submission of routine FDA filings, including Form FDA 2253 submissions for promotional materials, and maintenance of regulatory documentation and records. The Regulatory Affairs Associate will work closely with Regulatory Affairs leadership and cross-functional teams, including Marketing, Medical Affairs, Quality Assurance, R&D, and Legal, to support timely and compliant regulatory activities. This role is well suited for a regulatory professional with foundational pharmaceutical industry experience who is looking to expand their knowledge and responsibilities across labeling, promotional materials, regulatory submissions, and product lifecycle management. This role is hybrid, requiring three days a week onsite. Core Job Responsibilities Regulatory Labeling Support • Support the preparation, review, revision, and maintenance of product labeling, including Prescribing Information, Medication Guides, Instructions for Use, carton and container labeling, and other labeling components, as applicable., • Assist with implementation of FDA-approved labeling changes and ensure consistency across applicable labeling materials., • Coordinate labeling updates with internal stakeholders and external vendors., • Maintain accurate labeling histories, version control, and regulatory documentation., • Assist with proofreading and quality control reviews of labeling materials to ensure accuracy and consistency with approved content. Promotional Materials & FDA Form 2253 Submissions • Support regulatory review and submission of prescription drug promotional materials to FDA., • Prepare and submit Form FDA 2253 submissions and associated promotional materials in accordance with applicable FDA requirements and internal procedures., • Maintain accurate records of promotional material submissions, correspondence, and supporting documentation., • Coordinate with Marketing, Medical Affairs, Legal, and other stakeholders to facilitate timely regulatory review and submission of promotional materials., • Assist with tracking promotional material approvals, expiration dates, revisions, and submission status. Regulatory Submissions & Documentation • Assist with the preparation, compilation, quality control, and submission of routine regulatory filings to FDA., • Support submission activities for amendments, supplements, annual reports, labeling submissions, correspondence, and other regulatory documents, as assigned., • Assist with preparation and organization of documents for electronic regulatory submissions., • Perform quality control reviews to confirm submission documents are complete, accurate, and appropriately formatted., • Maintain regulatory submission trackers, correspondence, commitments, and other regulatory records., • Support senior Regulatory Affairs team members with larger or more complex regulatory submissions as needed. Product Lifecycle & Compliance Support • Support ongoing regulatory maintenance activities for approved pharmaceutical products., • Assist with tracking regulatory commitments, reporting requirements, submission deadlines, and agency correspondence., • Maintain current and accurate regulatory files in accordance with company procedures and applicable requirements., • Assist with regulatory research and review of FDA regulations, guidance documents, and other regulatory information., • Support implementation of regulatory changes affecting marketed products. Cross-functional Collaboration • Work collaboratively with Marketing, Medical Affairs, Quality Assurance, R&D, Legal, Supply Chain, and other functional groups on regulatory activities., • Provide routine regulatory support and information to internal stakeholders under the direction of Regulatory Affairs leadership., • Coordinate collection of documents and information needed to support regulatory submissions and other regulatory activities., • Participate in cross-functional meetings and communicate regulatory timelines, requirements, and action items. Regulatory Operations & Administrative Support • Maintain organized and inspection-ready regulatory records and electronic files., • Update regulatory databases, trackers, submission calendars, and document management systems., • Assist with obtaining, organizing, and maintaining regulatory documents and correspondence., • Support departmental procedures and process improvements designed to increase efficiency, consistency, and compliance., • Perform other regulatory affairs responsibilities and projects as assigned. Position Accountability / Scope • Execution Excellence: Completes assigned regulatory activities accurately, thoroughly, and within established timelines., • Attention to Detail: Maintains a high level of accuracy when reviewing labeling, promotional materials, regulatory submissions, and supporting documentation., • Compliance: Performs regulatory activities in accordance with applicable FDA requirements, company procedures, and established regulatory standards., • Organization: Effectively manages multiple assignments, submission deadlines, records, and priorities., • Collaboration: Works effectively with Regulatory Affairs leadership and cross-functional stakeholders to support company objectives., • Development: Builds regulatory knowledge and progressively takes ownership of routine regulatory activities and submissions. EDUCATION AND EXPERIENCE YOU’LL BRING Educational Background • Bachelor’s degree required, preferably in Life Sciences, Pharmacy, Chemistry, Biology, or a related scientific discipline., • Regulatory Affairs coursework or certification (e.g., RAC) is a plus but not required. Experience • 2–4 years of Regulatory Affairs experience in the pharmaceutical, biotechnology, or related life sciences industry., • Experience supporting regulatory activities for pharmaceutical products., • Experience with regulatory labeling and labeling-related activities required., • Experience preparing or supporting FDA Form 2253 submissions for prescription drug promotional materials strongly preferred., • Experience preparing, compiling, reviewing, or submitting routine FDA regulatory submissions., • Familiarity with regulatory requirements for marketed pharmaceutical products and product lifecycle activities., • Experience working with cross-functional teams such as Marketing, Medical Affairs, Quality Assurance, Legal, or R&D preferred. Technical Skills • Working knowledge of FDA regulations and guidance applicable to pharmaceutical products., • Familiarity with prescription drug labeling and promotional material requirements., • Basic understanding of electronic regulatory submissions and eCTD principles., • Strong document review, proofreading, and quality control skills., • Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook., • Experience with regulatory information management, document management, promotional review, or submission systems is a plus., • Ability to learn and effectively use new regulatory systems and software. Interpersonal Skills • Strong written and verbal communication skills., • Excellent attention to detail and commitment to producing accurate, high-quality work., • Strong organizational and time-management skills with the ability to manage multiple assignments and deadlines., • Ability to follow established procedures while identifying questions or issues requiring escalation., • Ability to work independently on routine assignments while seeking appropriate guidance on more complex regulatory matters., • Ability to work effectively in a dynamic, fast-paced environment and adapt to changing priorities., • Collaborative mindset and ability to work effectively with colleagues across multiple functional areas., • Demonstrated interest in developing a career in pharmaceutical Regulatory Affairs. WHAT WE OFFER Total compensation with salary and bonus is targeted for $70,000 - $90,000. Final pay determinations will depend on various factors such as geographical location, experience level, knowledge, skills, and abilities. Eton offers excellent benefits including: • Competitive medical, dental, and vision coverage, • 401K match, • Life, LTD and STD insurance coverages, • Generous paid time off including vacation, sick time, and holidays, • Opportunities for equity grants, • Ability to participate in employee stock purchase program Eton Pharmaceuticals is an Equal Opportunity Employer and will consider all applicants based on their job qualifications, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, or any other characteristic protected by federal, state or local law.