Job Description
Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Associate Director, Regulatory Affairs, Advertising and Promotion will provide regulatory advice regarding the communication of information related to assigned Alkermes products and disease areas. The role partners with Marketing, Marketing Operations, Regulatory, Medical Affairs, Sales, and Legal Departments to support initiatives and review external communication materials, develops and maintains positive working relationships within and across departments on promotional issues, and communicates with the FDA and contributes to health authority negotiations as necessary.
Alkermes has adopted a hybrid working environment. This role will operate in a flexible environment with 60% of time in the office and 40% from home, requiring onsite work at our Waltham, MA office at least 3 days per week. This position is not eligible for fully remote work.
Responsibilities
- Oversee and review product and disease state education materials for consistency with approved labeling and alignment with applicable FDA regulations and guidances; provide strategic support and alternative solutions to challenges.
- Serve as member of multi‑disciplinary teams such as Copy Clearance Committees, Global Regulatory Teams, and Global Labeling Teams; chair the Copy Clearance Committee.
- Maintain up‑to‑date knowledge of FDA laws, regulations, guidances, and the compliance environment related to advertising and promotion of pharmaceutical products and devices; advise relevant departments and help develop procedures to ensure compliance.
- Provide training on FDA regulations for advertising and promotion to employees and agents of Alkermes.
- Participate in efforts to minimize complexity of review processes.
- Build and maintain strong relationships with internal customers including Marketing, Marketing Operations, Legal, and Medical.
- Serve as primary contact for OPDP for assigned products and ensure timely and accurate submission of promotional materials to the FDA under Form FDA‑2253.
Qualifications
- High level of applied knowledge of FDA laws, regulations, guidance, and industry standards.
- Strong understanding of clinical trial design and interpretation of clinical data.
- Strong interpersonal and communication skills (written and verbal).
- Ability to shape strategies based on emerging trends.
- Ability to communicate business issues across all levels of the organization, negotiate business decisions, and work toward solutions to drive compliance.
Basic Requirements
- Bachelor’s degree in a health or science‑related field and/or an advanced degree.
- Minimum of 7 years of regulatory advertising and promotion review experience.
Preferred Requirements
- Up to 20% travel may be required.
- Strong interpersonal and communication skills (written and verbal).
- Ability to communicate complex issues clearly and concisely.
Salary and Benefits
The annual base salary for this position ranges from $185,000 to $197,000. The position is eligible for an annual performance pay bonus. Alkermes offers a competitive benefits package.
EEO Statement
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E‑Verify employer.
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