CMC Department

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.

Vision

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.

The role

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 CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
  • Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
  • Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
  • Responsible for triage of our client’s affiliate inquires and requests and when necessary consults with CMC RA Scientist for guidance in effort to prepare responses to questions.
  • Implement and in some cases interpret global regulations and guidances and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with our client affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.

Lead, Influence, Partner

• • Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.
  • Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.
  • Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes
  • Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies

Basic Qualifications

• • Bachelor’s Degree in a scientific or health sciences discipline (e.g. pharmacy, chemistry or related scientific discipline)

Knowledge of pharmaceutical drug development or industry-related experience preferred