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Manager, Regulatory Affairs US Advertising and Promotion The candidate will effectively presents pertinent information to appropriate cross-functional groups. Will functions 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 teams. Function as the expert within the job function and the product/disease state. Rapidly understands, evaluates and identifies issues/problems. Develop and execute departmental and therapeutic area strategies. Mentors staff, contractors interns and/or rotational students. Employ rigorous logic and methods to independently and effectively/creatively solve difficult problems. Probes multiple sources for answers. Identifies 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, makes good decisions based upon a mixture of analysis, experience and judgment. Must have Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology pharmacy, pharmacology, nursing, pharmacy). Relevant Master’s degree (Pharmacy, advanced scientific or law degree ) is preferred. Should have 6 years of pharmaceutical experience in Regulatory Affairs or relevant area. Should have strong communication skills, both oral and written. Experience in US Regulatory Affairs Advertising and Promotion is preferred.
Job ID: 1708801.
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