GRA CMC Lead

About the Job

As a GRA CMC Lead within the GRA Regulatory CMC & Devices (Vaccines) department, you’ll lead the management of a portfolio of projects and marketed products, develop CMC regulatory strategies, and represent the company in interactions with global Health Authorities.

Main Responsibilities

• Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products.
• Participate in Change Control assessment and ensure strong collaboration within CMC teams for the implementation of defined strategies.
• Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented, risks are identified, communicated and taken into account.
• Take into account requests from Health Authorities in an effective and timely manner and develop lasting relationships with them.
• Provide support for strategic negotiations with the Global Health...