OverviewCelldex 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.
Responsibilities
Regulatory Labeling Strategy
- Lead development and maintenance of USPI, PPI, Medication Guides, IFU, carton/container labeling, and 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
Promotional & Advertising Review
- Serve as Regulatory representative on MLR committees
- Review and approve promotional and commercial materials, including training, digital, congress, and disease awareness content
- Provide guidance on FDA/OPDP regulations, including fair balance and scientific exchange
Health Authority Engagement
- Support FDA interactions and labeling negotiations
- Develop regulatory strategies and submission responses
- Oversee submissions related to labeling updates, safety changes, and promotional materials
Cross-Functional Leadership
- Partner across Clinical, PV, Medical, Commercial, Legal, and Quality teams
- Provide regulatory guidance throughout development and commercialization
- Lead cross-functional labeling initiatives
Compliance & Process Improvement
- Monitor evolving FDA requirements
- Maintain SOPs for labeling and promotional review
- Support inspections and audits
- Drive continuous improvement within Regulatory Affairs
Qualifications
- 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
CompensationThe expected base salary range for this position is $176,659 to $229,427
We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Compensation for this role includes base salary, 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, and sick days. A summary of our benefits can be found on our careers page.
