Regulatory Affairs A&P Manager — Biologics

BioSpace; New Jersey; Presencial; USD 129 000 - 210 000; Tempo integral

Resumo da oferta

Regeneron seeks a Manager to join the Regulatory Affairs Advertising and Promotion team. You will apply clinical development knowledge with advertising and promotion regulations to support messages in BLAs/MAAs, overseeing therapeutic areas and ensuring compliant promotion.

You'll collaborate cross-functionally with Marketing, Medical Affairs and Legal, manage interactions with FDA OPDP, and help standardize promotional review processes while maintaining corporate integrity.

Qualificações

• Bachelor's degree in Life Sciences from an accredited college.
• Minimum 2 years experience in Regulatory Advertising and Promotion.
• Knowledge of pharma advertising regulations and FDA OPDP.
• Experience with FDA interactions preferred.
• Biologics experience a plus.

Responsabilidades

• Manage US regulatory activities for advertising and promotion of marketed products.
• Provide regulatory guidance to Commercial teams and Medical Affairs on conferences, disease awareness, and speaker programs.
• Review US and Global product and disease state materials to support corporate goals and regulatory compliance.
• Collaborate with Marketing, Medical Affairs and Legal across functions.
• Establish relationships with regulatory advertising and promotion professionals at partner companies.
• Lead interactions with FDA Office of Prescription Drug Promotion (OPDP) for assigned products.

Conhecimentos

Regulatory Affairs

Cross-functional collaboration

Regulatory guidance

FDA OPDP experience

Communication

Formação académica

Bachelor's in Life Sciences

Advanced degree preferred

Descrição da oferta de emprego

Regeneron seeks a Manager to join the Regulatory Affairs Advertising and Promotion team. You will apply clinical development knowledge with advertising and promotion regulations to support messages in BLAs/MAAs, overseeing therapeutic areas and ensuring compliant promotion.

You'll collaborate cross-functionally with Marketing, Medical Affairs and Legal, manage interactions with FDA OPDP, and help standardize promotional review processes while maintaining corporate integrity.