Category: Scientific & Clinical
Title: Senior Regulatory CMC Associate
Location: Shirley, NY - Relocation Package Offered
Type: Full Time, Salaried with benefits
Start Date: Immediate
Pharmaceutical Company in Shirley, NY is hiring a Senior Regulatory Associate with a focus in CMC submissions to join their team!
- Support the activities of the Regulatory Affairs department with strong focus in CMC.
- Lead the compilation, life-cycle, and compliance related to FDA submissions
- Mentor junior level CMC associates.
- Leverages technical expertise and considers the evolving regulatory landscape to navigate project, product, or process changes.
- Applies understanding of regulations to develop CMC information necessary to support each stage of new product development.
- Proposes regulatory strategies for commercial changes and R&D activities to Regulatory Management for confirmation.
- Authors and reviews regulatory submission documents ensuring accordance with FDA standards and regulatory guidance checks within specified timelines
- Communicates CMC requirements for product development with project and sub-team members to drive submission timelines and determine risks to filing, escalating to management when appropriate.
- Review and approve proposed changes to manufacturing processes, laboratory methods, and specifications.
- Authors and/or provides critical review of SOPs, protocols, technical documents, and stability data and reports to ensure suitability for regulatory filing.
- Bachelor’s degree in Chemistry, Microbiology, Pharmacy, or other scientific field required.
- Minimum of 4 years of Regulatory Affairs experience with a focus on CMC activities required. Ideally experience with US FDA NDA and ANDA submissions, facilitating the collection of deliverables from a manufacturing team.
- Experience with generic drugs or sterile products is highly desirable. CBE experience, experience with submissions life cycle would be great.
- Prior experience communicating directly with the FDA
- Prior experience acting as a lead for the CMC section of an NDA or ANDA submission from cradle to grave
- Experience working in a QC lab/stability prior to regulatory work is helpful
- Knowledge of FDA or EU drug regulations and cGMP requirements required.
- Strong organizational, interpersonal and communication skills (oral and written).
For immediate consideration, please send resume to Gina at email@example.com