Regeneron
Healthcare
Manager,RegulatoryAffairs,Advertising&Promotion
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“Manager, Regulatory Affairs, Advertising & Promotion at Regeneron. Skills: Regulatory affairs, Advertising and promotion, FDA interactions. Manage US regulatory activities. Advise on development of product messages”
Industry & Context.
What They're Looking For.
Must Have
2 total years relevant experience, Bachelor's degree from accredited college, Knowledge of regulations, guidelines, precedents
Nice to Have
Advanced Scientific degree preferred, Biologics experience is a plus, Experience working directly/indirectly with FDA, Experience with OPDP/APLB preferred, Support global promotional review desirable, Understanding of clinical trial recruitment materials desirable, Familiarity with labeling regulations desirable
What You'll Do.
Manage US regulatory activities
Advise on development of product messages
Provide regulatory advice and guidance
Review US and Global product materials
Collaborate cross functionally
Establish working relationship with co-promote partners
Lead and assist interactions with FDA OPDP
Maintain working relationship with FDA OPDP reviewers
Responsible for compliance with promotional material submissions
Monitor external environment for regulatory requirements
Advise on evolving regulatory requirements
Maintain vigilance with FDA promotional enforcement
Provide guidance on enforcement activities impact
Identify process improvement for promotional review
Establish portfolio wide standardization of policies
Cross train across products/indications
Ensure continuous Regulatory A&P support
Review key marketing application summary documents
Provide input during review cycles
Reflect commercialization objectives in submissions
Provide input to management during labeling development
Reflect commercialization objectives in labeling
How You'll Work.
Team & Collaboration
Cross functional teams; Marketing; Medical Affairs; Legal; Co-promote partner companies; FDA Office of Prescription drug Promotion
Communication Scope
Written communication; Verbal communication
Full Job Description
**Build our future together:** At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a **Manager** to join our**Regulatory Affairs Advertising and Promotion** team. In this role, you will apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). This individual will provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives, while maintaining the necessary state of compliance and corporate integrity. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. **When & where:** * Work Location: Sleepy Hollow, NY or Warren, NJ * Hybrid: 4 days per week on site **Discover your role:** * Management of US regulatory activities associated with advertising and promotion of the company’s marketed products. Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director. * Creatively contribute to the advise on the development of product messages and materials across multiple functional areas. * Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs * Provide rev
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