Associate Director/ Director of regulatory Affairs / Labeling, DDMAC
The incumbent will be responsible for developing and guiding the global regulatory strategy for assigned products, and serve as the core global regulatory representative on International Project Teams for assigned products and provide regulatory leadership.
Other responsibilities include (burt are not limited to):
Supervising the preparation of global regulatory submissions, and serving as the primary contact person with FDA for assigned products.
Monitoring programs (development projects and approved products) so they comply with the required Health Authority Regulations and Laws.
Reviewing and approving protocols, reports, and documents used in regulatory submissions.
Overseeing overall regulatory labeling function for assigned marketed products.
Providing regulatory input into US strategic marketing initiatives and policies regarding advertising and promotional activities.
Reviewing and approving all advertising and promotional materials for assigned products to insure that they comply with FDA regulations, as well as serving as primary contact person for DDMAC.
Developing, implementing and maintaining regulatory procedures regarding review of advertising and promotional materials for US marketed products
Keeping abreast of all pertinent laws, regulations and guidances as they pertain to regulatory strategies and submissions.
BS degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology, Pharmacology, Pharmacy or Nursing). PhD, PharmD, or comparable degree in the life sciences highly desired.
Minimum 10-12 years of regulatory experience, with a track record of completed filings of IND’s and NDA’s to health authorities.
Must have experience in interacting with the appropriate regulatory bodies (US and if possible EU and other countries).
Must possess in-depth knowledge of appropriate Code of Federal Regulations, Regulatory Guidance Documents (US and EU) and ICH Regulations.
Experience with regulatory reviews of promotional material and interaction with DDMAC.
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