Overview
CMC Regulatory Affairs Scientist Jobs in Rahway, NJ at The Fountain Group
Title: CMC Regulatory Affairs Scientist
Company: The Fountain Group
Location: Rahway, NJ
Details:
Pay for this position is 70.00 to 76.09 hourly depending on experience.
This position is a one-year contract with the possibility of extension or conversion to permanent.
Location: Rahway, NJ. Hybrid (3 days per week onsite, 2 remote)
Job Title: Associate Principal Scientist, Regulatory Affairs
Requirements:
Ph.D. with 4+ years, M.S. with 7+ years, or B.S with 10+ years relevant industry experience in related R&D sciences discipline (engineering, chemistry, biological sciences, pharmacy, veterinary, regulatory).
Must have a minimum of 2 years authoring CMC sections for regulatory submissions
Responsibilities:
The Associate Principal Scientist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance.
Responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products.
Work independently and effectively to manage and author regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations.
Review technical reports and scientific information provided to support regulatory submissions
Identify potential risks and propose mitigation strategies; communicate potential regulatory issues to management, as needed.
Provide regulatory assessments for post approval change proposals, filing strategies and timelines
Renewals and Geo-Expansions: Support license renewals and geo-expansion activities by supporting CORA requests for dossiers and GMP documentation
