Manager, CMC Vaccines Development Projects

Manager, CMC Vaccines Development Projects

Job purpose :

As a Manager, CMC Vaccines Development Projects , you will be responsible for the CMC regulatory activities in the investigational, development phase and commercial lifecycle management of our products.

In this role, you will…

• Drive the CMC strategy,coordinatethe timely preparationand author, as needed,technical (CMC) regulatorydocuments tosupport development and registration of new vaccinesorlifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, taking into accountthe evolving regulatory requirements.

• Provide regulatory advice and guidance to theTechnical Development Team and/orTechnical Life-Cycle Team (TLCT),Implementation Committee, Specification Review Committee, Technical Review Board, CMC Expert Panel,andprovideregulatory support to their partners inR&D,Quality Control, Manufacturing, QA and Supply. Ensure adequate interaction and partnership with the Global Regulatory Lead’s team in order to define proper regulatoryCMCfiling strategy.

• Lead CMC Regulatory discussionsduring interactions with Worldwide regulatory authorities.

• Ensure, in a continuous improvement mindset, regulatory compliance is maintained and sharebest-practices and learnings within the CMC Regulatory teamsand other impacted functions.

• Engage and lead CMC Subject Matter Expert activities, both internally (for increased compliance,harmonizationand efficiency)and externally(external advocacy and shapingtheregulatory environment).In a continuous improvement mindset, you will ensure regulatory compliance is maintained and share best-practices and learnings within the CMC Regulatory teams.

• Mentor or train staff. You may have direct line or lead management responsibility.

• May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.

• Deliver CMC regulatory strategy to support major inspections (eg PAI\’s) or quality incidents (PIRCs).

Why you?

Basic Qualifications & Experience:

• Bachelor\’s / Master’s degree or above in Chemistry, pharmacy, biological or closely related science advanced degree.

  Regulatory Affairs Certification (e.g. RAPS).

• Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.

• Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.

• Proven project management and multi-tasking skills.

• High ability to manage and direct multiple projects/teams

• Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel in a variety of settings

• Demonstrated ability to handle complex global CMC issues through continuous change and improvement.

Preferred Qualifications & Experience:

• Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership

• Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.

• Identified as CMC Regulatory expert in a specific subject area.

• Highly developed interpersonal, presentation and communication skills.

• Proven experience in supervising and training staff within an organization

Application closing date: Friday 8 August 2025

Please take a copy of the Job Description, as this will not be available post closure of the advert.

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If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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