Associate Director, Regulatory CMC
- New Jersey, USA
- Pharma & Biotech
Title: Associate Director, Regulatory CMC
Location: North Jersey
Duration: 1 Year (Extendable)
Pay Rate: $85-$95/hour (W2) - based on experience.
The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control strategy and documentation for new products and the commercial products within the portfolio.
The Associate Director CMC leads development of CMC strategy for Global Consumer Healthcare products. He or she is responsible for CMC support for both new and commercial products ensuring on-time development of appropriate Technical Regulatory Documents. For new products, the Associate Director is responsible for developing, gaining endorsement and executing CMC strategy to support on-time approval of new products. In this capacity, the position works closely with the development teams to ensure high quality documentation is provided and approved in accordance with project timelines.
POSITION DUTIES & RESPONSIBILITIES
- Provide leadership for the development of CMC Regulatory strategy for new product development projects.
- Work with Development Teams to ensure the on-time compilation of high quality CTD Module 3 and QOS documents.
- Define in collaboration with Regulatory Strategy the CMC requirements in order to register new products.
- Manage the dossier change requests (including manufacturing site transfers) of pharmaceutical products.
- Lead the development of technical documents for variation files
- Maintain knowledge of current industry requirements and standards for CTD Module 3 and QOS or equivalent.
- Bachelor's degree with 10 or more years of proven experience
- Master's degree with 6 or more years of proven experience
- Ph.D. with postdoctoral work or 4 or more years of proven experience
Skill & Competency Requirements:
- Significant experience in global CMC/Module 3 creation
- Expert in US and EU regulations with a focus on CMC
- Track record of successfully leading projects
- Experience dealing with global regulatory requirements
- Experienced in the US regulatory environment (NDA, IND, ANDA)
- Experience in post-approval CMC changes
- Fluent in English (German and/or French speaking is a plus)
Sthree US is acting as an Employment Business in relation to this vacancy.