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 involves significant cross-functional collaboration, independent decision-making, and strategic development. You will mentor staff and solve complex problems, contributing to departmental and therapeutic area strategies. This position offers remote work flexibility within the US, with a potential for a hybrid schedule near AbbVie sites.

Requirements

• Have a Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology pharmacy, pharmacology, nursing, pharmacy)
• Have 6 years pharmaceutical experience in Regulatory Affairs or relevant area
• 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 relevant Master’s degree (Pharmacy, advanced scientific or law degree)
• Have 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
• Remote work flexibility within the US, with a potential for a hybrid schedule near AbbVie sites