Senior Manager, Regulatory Affairs US Advertising and Promotion
The Senior Manager, Regulatory Affairs US Advertising and Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured for distributed to meet legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. Has department/group/site level influence and is generally recognized as an expert and resource for Regulatory. Shared knowledge and expertise with others in support of team activities. Analyzes broad scope implications of changing regulations and policies.
Key Responsibilities Include:
Key Responsibilities Include:
- Actively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie's interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights important facts in clear and concise manner.
- Represents department and participates in trade associations as needed. Develops working relationships with trade association managers.
- Summarizes findings, under supervision, in reports for distribution within AbbVie.
- Coordinates the operations efficiency and development of regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and aligned with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
- Develops and guides implementation strategies for promotional activities
- Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Ensures training and compliance with established regulations, guidance's, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Leads reports and assist in the development, training and mentoring of staff members.
- Effectively presents information to appropriate groups.
- Effectively delivers difficult messages to commercial organization without damage to relationships
- Establishes relationships with management and key partners (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) encouraging mutually helpful interactions and exchange.
- Bachelor's degree in science (biology, chemistry, microbiology immunology, medical technology pharmacy, pharmacology, nursing, pharmacy)
- Relevant Master's degree (Pharmacy, advanced scientific or law) preferred
- 7 years pharmaceutical experience in Regulatory Affairs or related area preferred
- Experience working in a complex and matrix environment and exhibits strong negotiation skills
- Strong interpersonal skills, both oral and written
- Experience in management capacity preferred
- Experience in US Regulatory Affairs Advertising and Promotion preferred