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Years of Experience
Date Last Verified
ProfileManager - Regulatory Affairs The candidate will combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Will have responsibility for one or two of the following: therapeutic area, products or multiple driver indications for a product. Develop and supervise regulatory professionals as needed. Have department/group/site level influence and is generally recognized as an expert and resource within the department. Support the Director in efforts to influence the regulatory environment. Share knowledge and expertise with others in support of team activities. Analyze broad scope implications of changing regulations and policies. 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. 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.
Qualification and Experience
The candidate must have a 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. Experience working in a complex and matrix environment is required. Experience in US Regulatory Affairs Advertising and Promotion is preferred.
Ref: 1708432 .