CMC Mature Products Regulatory Manager

Role Summary

CMC Mature Products Regulatory Manager responsible for the CMC regulatory activities in the commercial lifecycle management of GSK products.

Responsibilities

• Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
• Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
• Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications.
• Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
• Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
• Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
• Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
• Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.

Qualifications

• 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.
• Experience with drug development, manufacturing processes and supply chain.
• Experience with worldwide CMC regulatory requirements.
• Master’s degree in life sciences, related discipline preferred.
• Regulatory Affairs Certification (RAPS) preferred.

Skills

• Good time management and ability to plan, prioritise and coordinate multiple tasks; adapt to changing priorities to meet deadlines.
• Strong interpersonal, presentation and communication skills with established internal networks.
• Ability to influence and negotiate with company personnel and regulatory agencies.
• Experience developing and implementing regulatory strategies and evaluating their impact on project/product strategy.
• Experience handling global CMC issues through continuous change and improvement.

Education

• Bachelor’s degree required; Master’s degree preferred.

Additional Requirements

• Regulatory Affairs Certification (RAPS) preferred.