Manager Regulatory Affairs, US Advertising and Promotion
Manager Regulatory Affairs US Advertising & PromotionThe Manager regulatory affairs US advertising & promotion combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The Manager is responsible for 1-2 of the following: therapeutic area, products or multiple driver indications for a product; develops and supervises regulatory professionals as needed. The Manager has department/group/site level influence and is generally recognized as an expert and resource within the department; supports the Director in efforts to influence the regulatory environment; shares knowledge and expertise with others in support of team activities; and analyzes broad scope implications of changing regulations and policies.ResponsibilitiesEffectively presents pertinent information to appropriate cross-functional groupsFunctions independently in negotiation and decision-making for project related issues that have cross-functional impact. Provides inter-departmental direction and negotiation of regulatory issues. Independently recommends and implements changes to complex projects based on knowledge and expertise, accurate interpretation of government regulations, guidance's, promotional guidelines, corporate policies and management related considerations.Responsible for high impact and visible departmental project(s). Provides leadership in problem solving with teamsFunctions as the expert within the job function and the product/disease state. Rapidly understands, evaluates and identifies issues/problemsDevelops and executes departmental and therapeutic area strategiesMentors staff, contractors interns and/or rotational studentsEmploys rigorous logic and methods to independently and effectively/creatively solve difficult problems. Probes multiple sources for answers. Identifies hidden problems and issues beyond the obviousDevelops solutions for more complex issues with little guidance from managementProactively addresses and resolves issues having potential impact on working relationships and productivityUses problem solving skills to separate and combine tasks into efficient workflow, makes good decisions based upon a mixture of analysis, experience and judgment.This role will work a hybrid work schedule (3 days in office) from the Mettawa, IL; Irvine,CA or Florham Park, NJ AbbVie headquarters.Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.QualificationsMinimum: 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 including fellowships, Health Authority, ad promo, etc.)Relevant Master's degree (Pharmacy, advanced scientific or law degree) PharmD degree preferred plus 3 years of relevant industry experienceExperience working in a complex and matrix environmentExhibits strong negotiation skills plus strong communication skills, both oral and writtenExperience in US Regulatory Affairs Advertising and PromotionBenefitsWe 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 operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html.J-18808-Ljbffr