Regeneron
Healthcare
SeniorManager,RegulatoryAffairs,Advertising&Promotion
“Senior Manager, Regulatory Affairs, Advertising & Promotion at Regeneron. Skills: Regulatory Affairs, Advertising & Promotion, FDA interactions. Manage US and Global regulatory activities. Advise on development of product messages”
Industry & Context.
What They're Looking For.
Must Have
3 to 4 years regulatory affairs experience, Bachelor's degree from accredited College or University, Experience with pharmaceutical products
Nice to Have
Advanced degree preferred, Biologics experience a plus, Experience with FDA OPDP/APLB preferred, Ability to support global promotional review, Understanding of clinical trial recruitment materials, Familiarity with labeling regulations desirable
What You'll Do.
Manage US and Global regulatory activities
Advise on development of product messages
Provide regulatory advice to Commercial teams
Provide regulatory advice to Medical Affairs
Review US and Global product materials
Review disease state communications
Collaborate cross functionally
Manage communication with co-promote partners
Lead interactions with FDA OPDP
Maintain relationship with FDA OPDP reviewers
Submit promotional materials to FDA on Form 2253
Monitor external environment for regulatory requirements
Advise product teams on evolving requirements
Monitor FDA promotional enforcement
Provide guidance on enforcement impact
Provide input on process improvement
Cross train across products/indications
Review key marketing application documents
Provide input during review cycles
Provide input during labeling development
Provide input during labeling negotiation
How You'll Work.
Team & Collaboration
Marketing; Medical Affairs; Legal; Co-promote partners; FDA OPDP
Communication Scope
Written communication; Verbal communication
Applying for this Senior Manager, Regulatory Affairs, Advertising & Promotion role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Regeneron?
Real rants from real employees. Read before you apply.