Director, Regulatory Labeling
About The Position
Celldex Therapeutics is seeking an experienced Regulatory Affairs professional with demonstrated expertise in product labeling and promotional regulatory review to support development and commercialization activities across its portfolio. This individual will serve as the regulatory labeling lead, providing strategic and operational oversight for US prescribing information, core labeling documents, and promotional materials to ensure compliance with FDA regulations and company policies. The successful candidate will be part of the regulatory team and partner closely with Clinical Development, Medical Affairs, Commercial, Legal, Pharmacovigilance, and Quality teams to develop, maintain, and implement labeling strategies throughout the product lifecycle.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field required; advanced degree (MS, PharmD, PhD, JD) preferred
- 10+ years of Regulatory Affairs experience, including 5+ years leading labeling strategy for development and/or commercial products
- Proven experience developing and maintaining labeling documents (USPI, CCDS, Medication Guides, and packaging components)
- Experience supporting INDs, BLAs, and post-approval submissions, including participation in MLR/PRC review processes
- Strong knowledge of FDA labeling regulations, OPDP requirements, and promotional review guidance
- Experience with commercial-stage products; immunology or biologics background preferred
- Demonstrated success leading FDA labeling negotiations and driving strategic regulatory initiatives
- Strong scientific/clinical interpretation, communication, and cross-functional influence skills
- Excellent project management and organizational abilities, with capacity to thrive in a fast-paced biotech environment
Responsibilities
- Lead development and maintenance of US Prescribing Information (USPI), Patient Package Inserts (PPI), Medication Guides, Instructions for Use (IFU), Carton and container labeling, Company Core Data Sheets (CCDS)
- Define labeling strategies for INDs, BLAs, sBLAs, and post-approval changes
- Evaluate clinical, nonclinical, and safety data for labeling impact
- Ensure consistency across global labeling documents
- Digital and social media content
- Congress materials
- Disease awareness campaigns
- Partner across Clinical, PV, Medical, Commercial, Legal, and Quality teams
- Provide regulatory guidance throughout development and commercialization
- Lead cross-functional labeling initiatives
- Monitor evolving FDA requirements
- Maintain SOPs for labeling and promotional review
- Support inspections and audits
- Drive continuous improvement within Regulatory Affairs
Benefits
- annual discretionary bonus
- long term incentive
- 401(K) plan with employer contribution
- health care and other insurance benefits (for employee and family)
- paid holidays
- vacation
- sick days
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
