Manager, Regulatory Affairs

Summary

Join AbbVie as a Manager, Regulatory Affairs US Advertising & Promotion and leverage your scientific, regulatory, and business expertise to ensure product compliance. You will be responsible for 1-2 therapeutic areas, products, or indications, developing and supervising regulatory professionals. This role requires strong leadership, problem-solving, and communication skills, with a focus on navigating complex regulatory landscapes. The position offers a hybrid or remote work option within the US. AbbVie provides a comprehensive benefits package, including paid time off, health insurance, and participation in short-term and long-term incentive programs.

Requirements

• Have a Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) + 6 years of relevant industry experience (e.g. regulatory affairs, fellowship, Health Authority, ad promo, etc.)
• Have experience working in a complex and matrix environment
• Exhibit strong negotiation skills
• Have strong communication skills, both oral and written

Responsibilities

• Effectively present pertinent information to appropriate cross-functional groups
• Function independently in negotiation and decision-making for project-related issues that have cross-functional impact. Provide inter-departmental direction and negotiation of regulatory issues
• Independently recommend and implement changes to complex projects based on knowledge and expertise, accurate interpretation of government regulations, guidance’s, promotional guidelines, corporate policies, and management related considerations
• Be responsible for high impact and visible departmental project(s). Provide leadership in problem solving with teams
• Function as the expert within the job function and the product/disease state. Rapidly understand, evaluate, and identify issues/problems
• Develop and execute departmental and therapeutic area strategies
• Mentor staff, contractors, interns and/or rotational students
• Employ rigorous logic and methods to solve difficult problems independently, effectively, and creatively. Probe multiple sources for answers. Identify hidden problems and issues beyond the obvious
• Develop solutions for more complex issues with little guidance from management
• Proactively address and resolve issues having potential impact on working relationships and productivity
• Use problem-solving skills to separate and combine tasks into efficient workflow, make good decisions based upon a mixture of analysis, experience, and judgment

Preferred Qualifications

• Have a PharmD degree + 3 years of relevant industry experience (e.g. regulatory affairs, fellowship, Health Authority, ad promo, etc.)
• Have experience in US Regulatory Affairs Advertising and Promotion

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Participation in short-term incentive programs
• Participation in long-term incentive programs
• Remote work option within the US. Hybrid schedule may be requested if located near an AbbVie site