Project Manager, CMC Regulatory Affairs
GSK
5 months ago
Remote friendly (Waltham, MA)
United States
Operations
Project Manager, CMC Regulatory Affairs
Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
Key Responsibilities
- Responsible for the global CMC regulatory activities for assigned projects and responds to changing events and priorities.
- Develop CMC strategy (with managerial support) for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and early lifecycle management activities in accordance with applicable regulatory and scientific standards.
- Interpret and sometimes advise teams on regulations, guidelines, procedures, and policies relating to development, registration, and manufacture of medicinal products to expedite global CMC application submissions, reviews, and approvals.
- Ensure appropriate CMC regulatory aspects for clinical trials/product release are in place to avoid clinical holds and/or ensure continuity of market supply; ensure submissions meet regional requirements with flexibility and minimal unanticipated questions.
- Work in cross-functional matrix teams (regulatory, development, quality, manufacturing) to define proper regulatory CMC filing strategy.
- Maintain high quality standards and drive continuous improvement in response to the evolving regulatory environment.
- Maintain regulatory compliance and share best practices and learnings within CMC Regulatory and other impacted functions.
- Engage in CMC Subject Matter Expert activities internally.
- Sometimes deliver CMC regulatory strategy to support major inspections (e.g., PAIs) with managerial support.
Required Skills and Qualifications
- CMC regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages through early life cycle submissions.
- Degree in life sciences or related scientific discipline.
Additional Requirements/Skills
- Sound knowledge of drug development, manufacturing processes, and supply chain (may include specialized expertise).
- Knowledge of worldwide CMC regulatory requirements and a track record of delivering compliant dossiers, particularly for new medicines.
- Strong time management; ability to plan, prioritize, coordinate multiple tasks, and adjust to changing priorities under tight deadlines.
- Demonstrated knowledge of project management components (scope, time, cost, quality, integration, influence/negotiation, communications, risk, scenario planning) across initiating, planning, executing, monitoring, controlling, and closing.
Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
Key Responsibilities
- Responsible for the global CMC regulatory activities for assigned projects and responds to changing events and priorities.
- Develop CMC strategy (with managerial support) for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and early lifecycle management activities in accordance with applicable regulatory and scientific standards.
- Interpret and sometimes advise teams on regulations, guidelines, procedures, and policies relating to development, registration, and manufacture of medicinal products to expedite global CMC application submissions, reviews, and approvals.
- Ensure appropriate CMC regulatory aspects for clinical trials/product release are in place to avoid clinical holds and/or ensure continuity of market supply; ensure submissions meet regional requirements with flexibility and minimal unanticipated questions.
- Work in cross-functional matrix teams (regulatory, development, quality, manufacturing) to define proper regulatory CMC filing strategy.
- Maintain high quality standards and drive continuous improvement in response to the evolving regulatory environment.
- Maintain regulatory compliance and share best practices and learnings within CMC Regulatory and other impacted functions.
- Engage in CMC Subject Matter Expert activities internally.
- Sometimes deliver CMC regulatory strategy to support major inspections (e.g., PAIs) with managerial support.
Required Skills and Qualifications
- CMC regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages through early life cycle submissions.
- Degree in life sciences or related scientific discipline.
Additional Requirements/Skills
- Sound knowledge of drug development, manufacturing processes, and supply chain (may include specialized expertise).
- Knowledge of worldwide CMC regulatory requirements and a track record of delivering compliant dossiers, particularly for new medicines.
- Strong time management; ability to plan, prioritize, coordinate multiple tasks, and adjust to changing priorities under tight deadlines.
- Demonstrated knowledge of project management components (scope, time, cost, quality, integration, influence/negotiation, communications, risk, scenario planning) across initiating, planning, executing, monitoring, controlling, and closing.