Senior Manager, Regulatory Affairs US Advertising and Promotion - Immunology

Responsibilities

• Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
• Summarizes findings, under supervision, in concise reports for distribution within AbbVie
• Development and guides implementation strategies for promotional activities
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
• Effectively presents pertinent information to appropriate cross-functional groups.
• Effectively delivers difficult messages to commercial organizations without damage to relationships
• Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
• This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA; Washington, D.C.; or Rockville, MD.
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Minimum: Bachelor's degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
• Experience working in a complex and matrix environment and exhibits strong negotiation skills
• Strong communication skills, both oral and written
• Experience in management capacity preferred
• Experience in US Regulatory Affairs Advertising and Promotion
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.
• AbbVie is an equal opportunity employer and is committed to opera

Benefits

Additional Information

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

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