About the role
Lead CMC regulatory activities in the late development and/or lifecycle management of GSK products.
About the responsibilities
* Drive the CMC strategy, coordinate the timely preparation and authorship of technical (CMC) regulatory documents to support lifecycle maintenance submission content, in accordance with applicable regulatory and scientific standards, considering evolving regulatory requirements.
* Identify risks related to submission data and information packages, and communicate well-defined risk mitigation strategies. Play a key role in major post-approval filing activities (e.g., significant manufacturing changes or key regulatory interactions).
* Mentor or train staff. Manage project activities for multiple complex projects and teams, providing strategic direction and data assessment across departments. Establish internal and external networks to understand organizational constraints within a highly complex environment.
* Engage with and lead CMC Subject Matter Expert activities, both internally and externally, to enhance compliance, harmonization, and efficiency, and to influence the regulatory environment.
* Support major inspections (e.g., PAI) or quality incidents (PIRCs) by delivering CMC regulatory strategy.
* Accountable for submission content, advising on regulations, guidelines, procedures, and policies related to development, registration, and manufacturing to expedite approvals.
* Ensure all CMC regulatory aspects for product release are in place to maintain market supply, and that submissions meet regional requirements to allow maximum flexibility with minimal questions.
* Innovate and improve CMC regulatory processes, policies, and systems to enhance departmental efficiency and quality. Play a key role in post-approval activities involving manufacturing changes or regulatory interactions.
* Communicate complex regulatory issues across the company and with external agencies, managing agency interactions confidently and assertively.
* Operate independently on regulatory matters, communicating sensitive issues promptly and appropriately.
* Participate in corporate evaluations and provide CMC regulatory support for in-licensing and divestment projects.
About you
* Master’s or PhD in Life Sciences or related field.
* Deep knowledge of drug development, manufacturing, and supply processes.
* Recognized CMC Regulatory expert in a specific area.
* Extensive knowledge of global CMC regulatory requirements and ability to influence the regulatory environment.
* Proven project management and multi-tasking skills.
* Experience managing multiple projects and teams.
* Ability to lead major post-approval filings and regulatory interactions.
* Fluency in English and French.
Preferred Qualifications & Skills
* Strong influencing and negotiation skills with regulatory agencies and industry bodies.
* Ability to handle complex global CMC issues and drive continuous improvement.
#LI-GSK
#GSKVaccines
If you have a disability and require assistance during the selection process, please let us know your specific needs to make suitable arrangements.
Why GSK?
Uniting science, technology, and talent to get ahead of disease together.
GSK is a global biopharma company focused on vaccines, specialty, and general medicines, investing in immune system science and new technologies across core therapeutic areas.
Our success depends on our people. We aim to be a place where employees feel inspired, valued, and encouraged to grow and maintain wellbeing. Join us at this exciting moment in our journey to get Ahead Together.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment agencies without prior written authorization. All agencies must contact GSK’s HR department for approval before referring candidates. Unauthorized actions will not be liable for fees.
#J-18808-Ljbffr