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Manager, Regulatory Affairs Advertising and Promotion The candidate: Functions as the expert within the job function and the product(s)/disease state(s). Rapidly identifies, understands, and evaluates issues while exercising good judgment. Employs effective logic and methods to independently and creatively solve difficult problems. Probes multiple sources for answers, and identifies hidden problems and issues beyond the obvious. Develops solutions for more complex issues with appropriate level of guidance from management. Functions independently in negotiation and decision-making for cross-functional projects with managerial oversight, as appropriate. Recommends and implements changes to complex projects based on knowledge and expertise, including accurate interpretation of government regulations and FDA guidance, other external promotional guidelines, corporate policies, and management-related considerations. Effectively presents pertinent information to appropriate cross-functional teams, and provides leadership in problem solving. Proactively addresses and resolves issues having potential impact on working relationships and productivity. Uses problem solving skills to separate and combine tasks into efficient workflow, Provides inter-departmental assessment of regulatory issues. Responsible for high impact and visible departmental project(s). Mentors staff, contractors interns and/or rotational students. Develops and supervises regulatory professionals as needed. Bachelorâ€™s degree in science (biology, chemistry, microbiology immunology, medical technology pharmacy, pharmacology, nursing, pharmacy) is essential. Relevant Masterâ€™s degree (Pharmacy, advanced scientific or law degree) preferred. Must have 3-5 years of pharmaceutical experience in Regulatory Affairs or relevant area. Should have experience working in a complex and matrix environment. Experience in US Regulatory Affairs Advertising and Promotion preferred.
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