CMC Mature Products Regulatory Manager

Role Summary

The CMC Mature Products Regulatory Manager is responsible for the global CMC regulatory activities in the commercial lifecycle management of GSK products. The role leads CMC strategy development for submission documents to support marketed product lifecycle management in accordance with regulatory and scientific standards. It collaborates with regulatory, development, quality and manufacturing teams to define appropriate regulatory CMC filing strategies and maintains high quality standards in response to evolving regulatory requirements. Location includes multiple sites: USA – Pennsylvania, Belgium – Wavre, GSK HQ (Poznan Grunwaldzka), USA – Massachusetts – Waltham, USA – North Carolina – Durham.

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

• 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 effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
• Preferred: Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects.
• Preferred: Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of 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 out and recommends 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 change or key regulatory interactions in lifecycle management).
• Preferred: Regulatory Affairs Certification (RAPS).