Regulatory Affairs Associate Director-Pharma

Company: Biolink360
Location: Newark
Posted on: April 8, 2025

Job Description:

Title: Associate Director of Regulatory Affairs - Ad PromoReports to: EVP Regulatory AffairsDirect Reports: 1Location: Northern NJ - Morris CountySalary Range: $150,000 - $190,000Work Location: HybridExperience 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 with over 40 years of experience, over 300 products, and nearly 4,000 employees. The person hired for this role will focus on the women's health portfolio, particularly following a recent FDA approval. The individual will set strategy and execute plans with a collaborative and passionate team.Responsibilities

• Prepare and submit 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 comply 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 version 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 the 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.Key Words: Regulatory Advertising & Promotion Policy, Adpromo, Ad Promo, Regulatory Affairs, RAC, PharmD, Scientist, Technical Writer, Labeling, RA, Reg
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Keywords: Biolink360, Newark , Regulatory Affairs Associate Director-Pharma, Executive , Newark, New Jersey