Associate Director, Regulatory Advertising and Promotion
About The Position
Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Associate Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication of information related to assigned Alkermes products and disease areas. Partners with other personnel in Marketing, Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of initiatives and review of external communications materials. Develops and maintains positive working relationships within and across departments in relation to promotional issues. Communicates with FDA and contributes to health authority negotiations as necessary.
Requirements
- Associate Director, Regulatory Affairs, Advertising and Promotion role
- Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling
- Providing sound regulatory advice related to communication of information related to assigned Alkermes products and disease areas.
- Partners with other personnel in Marketing, Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of initiatives and review of external communications materials.
- Develops and maintains positive working relationships within and across departments in relation to promotional issues.
- Communicates with FDA and contributes to health authority negotiations as necessary.
Nice To Haves
- Experience in the biopharmaceutical industry.
- Knowledge of neuroscience and related disorders.
- Experience with regulatory submissions and health authority interactions.
Responsibilities
- Providing sound regulatory advice related to communication of information related to assigned Alkermes products and disease areas.
- Partnering with other personnel in Marketing, Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments in support of initiatives and review of external communications materials.
- Developing and maintaining positive working relationships within and across departments in relation to promotional issues.
- Communicating with FDA and contributing to health authority negotiations as necessary.
Benefits
- Hybrid working environment
- Certified as a Great Place to Work in the U.S.
- Named one of Massachusetts’ Top Places to Work
- Best Place to Work in Greater Cincinnati
- Recognized as a Best Place to Work in BioPharma
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
