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.