CMC-Development Regulatory Associate (LO A008367)

The purpose of the CMC (Chemistry, Manufacturing, and Controls) Regulatory Associate, leads the operational and technical aspects of clinical trial and global marketing authorization submissions for the small and large molecule portfolios in partnership with the Global Regulatory Affairs CMC Regulatory Scientists. The Regulatory Associate partners with the CMC Scientists to create and manage submission documents and provides guidance on structure and content placement. The Regulatory Associate works within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The Regulatory Associate utilizes submission process expertise to facilitate project management expectations across projects. The scope of work includes global regulatory requirement assessment and understanding strategy development in relation to submission management.


Role Responsibilities
1.Regulatory & Drug Development Expertise

• Partner with the CMC Regulatory Scientists to drive the execution of submission planning for clinical trials and global registration submissions.
• Review regulatory strategies across molecules and identify opportunities to simplify and streamline submissions for markets and/or regions.
• Interpret and implement global agency regulations, guidance and regulatory precedence into submission processes and publishing standards
• Lead CMC submission management process by providing expertise on internal processes, electronic submission regulations and guidance regarding technical content and structure requirements.
• Own the submission management process at the molecule/project submission level to ensure all required electronic records are timely, complete, and accurate.
• Serve as the CMC operational lead for global clinical trial applications and registration planning and execution, including critical chain status updates.
• Understand and support the regulatory processes that enable review and release of clinical trial materials.
• Manage CMC databases and/or information tools, prepare periodic or special request submission metrics reports to enable CMC staff to identify and address global agency trends.

• Lead CMC submission management processes by leveraging expertise to optimize internal processes and tools. Anticipate and resolve process and/or timeline issues.
• Develop collegial and mutually productive relationships across the company’s components, partner companies, Affiliates and regulatory submission centers that enable a team environment of developing quality submissions in a timely fashion.
• Partner with the Regulatory Scientist to plan, facilitate and document internal regulatory draft review meetings, and/or submission integration/planning sessions.
• Lead communication and transfer of registration submission commitments between CMC and Site Regulatory Affairs groups.
• Create an environment within Global Regulatory Affairs and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions.

• Subject matter expert (SME) responsible for the technical evaluation, implementation and documentation of CMC regulatory content, submission procedures/guidance, submission integration, and submission tracking.
• Comprehensive knowledge of evolving global agency publishing standards
• Comprehensive knowledge and skills related to systems, processes and standards.
• Demonstrate expertise at planning CMC submissions.

• Bachelor’s Degree. Scientific or health sciences discipline preferred (e.g. pharmacy, nursing, chemistry or related scientific discipline) could enable further long-term advancement opportunities
• Knowledge of drug development process
• Demonstrated ability to manage operational requirements in a regulated environment
• Demonstrated written, spoken, and presentation communication
• Demonstrated attention to details, negotiation and influence skills
• Demonstrated ability to effectively prioritize and manage competing priorities