Regulatory Manager, Strategy - CMC RA Vaccines Development Projects

About the role

Responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.

About the responsibilities

• Be responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities
• Be responsible for CMC strategy development, 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 the applicable regulatory & scientific standards.
• Understand, interpret and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the submission, review and approval of global CMC applications.
• Ensure all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply. Ensure information submitted in clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
• Work 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.
• Maintain high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Ensure regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
• Engage in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
• Will sometimes deliver CMC regulatory strategy to support major inspections (e.g. PAI's) with managerial support.

About you

• BSc Life sciences or related scientific discipline (or PhD)
• Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions.
• Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.
• Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.
• 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.
• 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. Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings.
• Strong interpersonal, presentation and communication skills with established internal networks.
• May be identified as CMC Regulatory expert in a specific subject area.
• Proactively seeks out and recommends process improvements
• Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.
• Demonstrated ability to handle global CMC issues through continuous change and improvement
• Developing experience in major filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/pre-Phase 3 or other regulatory interactions in early development.)