CMC Mature Products Regulatory Manager

Role Summary

Responsible for the CMC regulatory activities in the commercial lifecycle management of GSK products. This role supports global CMC strategy development, regulatory submissions for marketed products, and compliance across product release and lifecycle activities. Location spans multiple sites including USA - Pennsylvania - Upper Providence; Belgium - Wavre; GSK HQ; Poznan Grunwaldzka; USA - Massachusetts - Waltham; USA - North Carolina - Durham, Ware.

Responsibilities

• Global CMC regulatory activities for assigned projects and responsiveness to changing events and priorities.
• CMC strategy development for submission documents to support marketed product lifecycle management in accordance with regulatory and scientific standards.
• Advise teams on regulations, guidelines, procedures, and policies related to manufacture and control of medicinal products to expedite submission, review, and approval of global CMC applications.
• Ensure appropriate CMC regulatory aspects for product release, ensuring continuity of market supply; ensure lifecycle maintenance submissions meet regional requirements, enabling maximum supply/production/quality flexibility with minimal questions.
• Collaborate in cross-functional matrix teams with regulatory, development, quality, and manufacturing to define proper regulatory CMC filing strategy.
• Maintain high quality standards and drive continuous improvement and innovation in response to the evolving regulatory environment.
• Share best practices and learnings to maintain regulatory compliance within CMC Regulatory teams and impacted functions.
• Engage in CMC Subject Matter Expert activities to increase compliance, harmonisation and efficiency.
• Deliver CMC regulatory strategy to support major inspections (e.g., PAIs) with managerial support as needed.

Qualifications

• Required: Bachelor’s degree in life sciences related discipline with 3+ years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions.
• Required: Experience with drug development, manufacturing processes and supply chain.
• Required: Experience with worldwide CMC regulatory requirements.
• Preferred: Master’s degree in life sciences, related discipline preferred.
• Preferred: Good time management skills with the ability to plan, prioritize, and coordinate multiple tasks and adapt to changing priorities to meet deadlines.
• Preferred: Continued professional growth in global regulatory affairs including communication of evolving trends and policies; broadened knowledge across regulatory functions to understand wider implications.
• Preferred: Experience influencing and negotiating with company personnel and regulatory agencies in various settings.
• Preferred: Strong interpersonal, presentation, and communication skills with established internal networks.
• Preferred: May be identified as CMC Regulatory expert in a specific subject area.
• Preferred: Proactively seeks process improvements.
• Preferred: Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
• Preferred: Demonstrated ability to handle global CMC issues through continuous change and improvement.
• Preferred: Developing experience in major post-approval filing activities (significant manufacturing changes or key regulatory interactions in lifecycle management).
• Preferred: Regulatory Affairs Certification (RAPS).

Skills

• Regulatory strategy development and implementation for CMC across global lifecycle stages.
• Cross-functional collaboration with regulatory, development, quality, and manufacturing teams.
• Strong interpersonal, presentation, and communication skills; ability to influence at multiple organizational levels.
• Ability to navigate evolving regulatory environments and drive continuous improvement.
• Capability to engage in inspections and provide SME input as needed.

Education

• Bachelor’s degree in life sciences or related discipline.
• Master’s degree in life sciences or related discipline preferred.