Regulatory Affairs Associate Director-Pharma

Overview Title: Associate Director of Regulatory Affairs - Ad Promo Reports to: EVP Regulatory Affairs Direct Reports: 1 Location: Northern NJ - Morris County Salary Range: 150-190K Work Location: Hybrid Experience Needed: Solid foundation in ad/promo regulatory affairs, with a total of 7 years in Pharma Regulatory. This is a working Manager position, and as the team grows, leadership responsibilities will expand. Our client is a global pharma company that has over 40 years of experience, with over 300 products and close to 4000 employees. The person hired for this role will have a concentration in the women’s health portfolio. This is an established company based in Northern New Jersey, with a recent FDA approval which will largely be the initial focus of this role. The person hired will set strategy and execute the plan with a collaborative and passionate team. Responsibilities Responsible for preparing and submitting NDA annual reports, supplements, and other submissions required for marketed drug products in eCTD format. Provide regulatory assessment of CMC change controls. For changes requiring the filing of supplemental NDAs, prepare and submit relevant documents and updates to the dossiers for approval. As a member of the Promotional Review Committee, ensure the review and approval of branded and unbranded promotional materials are in regulatory compliance with relevant laws and regulations. Lead the implementation of labeling changes for drugs, medical devices and dietary supplements including tracking and maintaining NDC/NHRCI numbers and labeling component and versions numbers. Ensure regulatory compliance of marketed dietary supplements in terms of labeled claims and promotional materials. Maintain and update establishment registrations and drug listings. Maintain and update regulatory SOPs and support the review and implementation of policies and procedures. Represent the company in NJ State and FDA site inspections. Act as the designated representative for company’s manufacturer and wholesale distributor licenses. Qualifications Bachelor’s degree in Chemistry or equivalent Fluent in English. Proficiency in Spanish is desirable. 7+ years of experience in regulatory affairs. #J-18808-Ljbffr Biolink360