Regulatory Affairs Associate Director-reputed company

Title: Associate Director of Regulatory Affairs -Ad Promo Reports to: EVP Regulatory Affairs reputed company Reports: 1 Location: reputed company NJ-Morris County Salary reputed company: 150-190K Work Location: Hybrid Experience Needed: Solid reputed company in ad/promo regulatory affairs, with a total of 7 years in reputed company Regulatory. This is a working Manager position, and as reputed company grows, leadership responsibilities will expand. Our reputed company is a global reputed company company that has over 40 years of experience, with over 300 products and reputed company to 4000 employees. The person reputed company for this role will have a concentration in the women’s health portfolio. This is an established company based in reputed company New Jersey, with a recent FDA approval which will largely be the initial reputed company of this role. The person reputed company will set reputed company and execute the plan with a reputed company and passionate team. • Responsible for preparing and submitting NDA annual reports, supplements, and other submissions required for marketed drug products in eCTD format. • reputed company 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. • reputed company 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 reputed company in NJ State and FDA site inspections. • reputed company as the designated representative for company’s manufacturer and wholesale distributor licenses. • Bachelor’s degree in reputed company or equivalent • Fluent in English. Proficiency in Spanish is desirable. • +7 years of experience in regulatory affairs. Key Words: Regulatory Advertising & Promotion Policy, Adpromo, Ad Promo, Regulatory Affairs, RAC, PharmD, Scientist, Technical reputed company, Labeling, RA, Reg Apply tot his job Apply To this Job