Senior Manager of Regulatory Affairs for Advertising and Promotion
2 weeks ago
Position: Senior Manager of Regulatory Affairs for Advertising and Promotion
Compensation: $190,000 to $220,000
Overview:
A leading global healthcare organization, committed to enhancing lives through innovative healthcare solutions across pharmaceuticals, medical devices, and consumer health products, is seeking a Senior Manager of Regulatory Affairs for Advertising and Promotion. This role is pivotal as the Advertising and Promotion team expands, and the selected candidate will leverage their expertise to support the mission of improving health outcomes.
Key Responsibilities:
- Assessing advertising and promotional materials, new initiatives, and launch strategies for designated products to ensure adherence to regulatory standards. Timely and precise evaluations are essential to meet established deadlines and requirements.
- Formulating and executing regulatory strategies and solutions to guarantee that all advertising and promotional content complies with regulatory mandates and corporate policies.
- Keeping abreast of FDA activities, including enforcement actions and guidance documents, to evaluate their implications for company products.
- Ensuring that promotional package inserts and critical safety information are updated as required.
Qualifications:
- A Bachelor's degree in Life Sciences or a related discipline is mandatory; an advanced degree (MS, MD, PhD, PharmD) is preferred.
- A minimum of 8 years of experience in the pharmaceutical sector, with at least 4 years focused on the review of advertising and promotional materials for prescription products.
- Proficient understanding of the NDA and labeling processes for prescription products.
- Completion of training courses in advertising and promotional review.
- Excellent interpersonal skills, with the ability to collaborate effectively within a team and strong communication capabilities.
Employee Benefits:
- Comprehensive Medical, Dental, and Vision insurance.
- 401(k) plan with matching contributions.
- Tuition reimbursement programs.
- Commuter benefits.
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