GRA – Chemistry, Manufacturing, and Control (CMC) is responsible for regulatory strategy, submissions and regulator interactions associated with all products in development up to and including initial market applications in all countries around the globe. GRA-CMC is also responsible for the regulatory strategy and post approval submissions for Commercial Products to ensure reliable supply and continuous improvements. This includes small molecules, biotechnology, Insulin products, devices, and drug / device combination products.
They work in collaboration with other areas of GRA, Product Research & Development, Technical Services / Manufacturing Sciences, Quality, Product Delivery PM, PPM, and PDS to develop CMC regulatory strategies, provide regulatory risk assessments, and implement regulatory processes to support products and CMC teams.
To be Industry Leading in Application of CMC Regulatory Science, Leveraging Quality by Design to Obtain Timely Approvals that Enable Continuous Improvements in Product Quality and Manufacturing Processes.
My client is looking for an associate to lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. This exciting opportunity will enable you to utilize your project management and communication skills to advance the submission process for new molecules. You will also partner with GRA-CMC Scientists to help build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission related Ministry of Health responses or our client’s affiliate questions. You will work within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working understanding of internal procedures, guidances and regulatory precedence. You will triage and lead the communications between our client’s Affiliates, GRA-CMC Scientists, and Specialists. You will be the point person for communication regarding submission tracking requirements to both GRA-CMC Scientists and internal customers.
Regulatory & Drug Development Expertise
Lead, Influence, Partner
Knowledge of pharmaceutical drug development or industry-related experience preferred
Clinical Trial Associate – Spanish (Fluent) Our client is a global leading pharmaceutical company who are searching for a...Apply For This Job
Italian fluent Billing/Invoicing Customer Support Enter account payable adjustments into the invoicing systems and handle exceptions and discrepancies resolutions Research,...Apply For This Job
Clinical Contracts & Budgets fluent German Key Responsibilities: The Associate plays a critical role in communicating and negotiating...Apply For This Job
Customer Meeting Support Analyst (Legal Support) Responsibilities: Be seen as a “go-to” information resource for Contracting to Pay queries...Apply For This Job
Job description Our client is one of the most prestigious brands and global players on the luxury market. Quality, excellence...Apply For This Job