Senior Manager, Regulatory Affairs

Summary

Join AbbVie as a Senior Manager of Regulatory Affairs for US Advertising and Promotion. This role combines scientific, regulatory, and business expertise to ensure product compliance. You will review promotional materials, provide regulatory guidance, and participate in pipeline commercialization. The position requires strong communication and negotiation skills, experience in a matrix environment, and a background in pharmaceutical regulatory affairs. This role offers remote work options within the US and a comprehensive benefits package.

Requirements

• Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology pharmacy, pharmacology, nursing, pharmacy)
• 7 years pharmaceutical experience in Regulatory Affairs or related area
• Experience working in a complex and matrix environment and exhibits strong negotiation skills
• Strong communication skills, both oral and written

Responsibilities

• Review promotional and non-promotional communications for on-market products to ensure compliance with applicable laws and regulations, as well as internal policies and procedures
• Provide regulatory guidance for data and information consistent with product labeling
• Participate in pipeline commercialization activities; review and contribute to target product claims, target product labeling
• Act as a key contributor on cross-functional teams and workstreams for pipeline and on-market products
• Develop and guide implementation strategies for promotional activities
• Broadly apply regulatory/technical knowledge of government regulations and skills across therapeutic areas
• Proactively capture and disseminate activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintain awareness of pending changes to communicate impact and relevance within US Advertising and Promotion department
• Represent department and participate in trade associations as needed
• Summarize findings, under supervision, in concise reports for distribution within AbbVie
• If assigned staff, oversee their operations, productivity, and development
• Ensure departmental training and compliance with established regulations, FDA guidance, promotional guidelines, and SOPs related to advertising and promotion regulations. If applicable, manage direct reports and assist in the development, training and mentoring of staff members
• Effectively present pertinent information to appropriate cross-functional groups
• Effectively deliver difficult messages to commercial organization while maintaining relationships
• Establish good working relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Market Access, Public Affairs, etc.), fostering mutually beneficial interactions and exchange

Preferred Qualifications

• Relevant Master’s degree (Pharmacy, advanced scientific or law)
• Experience in management capacity
• Experience in US Regulatory Affairs Advertising and Promotion

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs
• This role can be based remotely within the US