Head, Vaccines Development Projects

Head , Vaccines Development Projects - CMC R egulatory A ffairs

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

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Our approach to R&D

Position Summary

Join GSK as Head, Vaccines Development Projects - CMC Regulatory A ffairs, where you'll lead impactful initiatives that advance vaccine development and make a meaningful difference in global health. In this role, you'll collaborate with cross-functional teams, drive strategic decision-making, and ensure the successful delivery of complex projects. We value leaders who are innovative, inclusive, and committed to achieving results. This is your opportunity to grow professionally while contributing to GSK's mission of uniting science, technology, and talent to get ahead of disease together.

In this role you will be accountable for CMC (Chemistry, Manufacturing and Controls) Regulatory activities for GSK's Vaccine development products, including in-licensed assets through to Early Lifecycle and transition of CMC Regulatory accountability to the Mature Products CMC Regulatory department. Additionally, you will lead the department accountable for delivering CMC strategy and advice for GSK's Vaccine development products, plus ensure timely advice and strategy to project teams to secure regulatory approvals for clinical trials and marketing applications globally. These goals are achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements.

Responsibilities

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include the following:

• Leads and oversees the development and execution of Vaccine CMC Regulatory strategies, ensuring alignment with GSK's goals and regulatory requirements.
• Establishes and directs appropriate agency communications including End of Phase 2, Pre BLA, Scientific advice, and ad-hoc product specific agency dialogue.
• Ensures risk assessments are conducted, and appropriate mitigation and treatment plans are defined for product developments, effectively liaising with business partners and customers across Product Development, Commercial Supply Chain, GRA and product development teams.
• Provides appropriate GSK representation and input to product specific inspections for CMC aspects to secure approvals of new products and ensure GSK learning and continuous improvement.
• Directs global teams which provide the primary interface with the CMC Development and commercial supply organisations for GSK global development products including in licensed assets.
• Responsible for managing direct agency interface for CMC product specific aspects for all GSK development and in-licensed assets and to ensure effective negotiation of CMC agreements on behalf of R&D CMC Development and the Commercial Supply Chain.
• Proactively manage budget and resource requirements for the department.
• Liaises with the heads of CMC Regulatory Development Projects across modalities to drive aligned approaches for developments and filings, and with the CMC RA mature Products organisation to ensure an integrated regulatory strategy for products as they move towards commercial supply.
  Manages, coaches, and mentors staff across CMC RA.

Basic Qualifications

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in life sciences, pharmacy, or a related field.
• Extensive experience in vaccine physical product development, CMC regulatory affairs, or related areas.
• Extensive expertise of diverse market environments and requirements. Proven ability to assimilate new and emerging requirements and establish optimized approach in global context.
• Strong understanding of CMC regulatory requirements and processes for vaccine development.
• Extensive development experience including previous roles within product development, deep expertise and understanding of regulatory agencies worldwide and proven ability to effectively interface and communicate with global regulatory agencies.
• Experience managing teams and budgets effectively.
  Excellent communication and interpersonal skills, with the ability to influence and collaborate across diverse teams.

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Advanced degree (e.g., PhD, MBA) in a relevant field.
• Experience in managing vaccine development projects from early-stage research to commercialization.
• Knowledge of global regulatory trends and emerging policies in vaccine development.
• Demonstrated ability to drive innovation and process improvement in a complex organizational setting.
• Experience engaging with external stakeholders, including regulatory agencies and industry groups.
  Strong leadership skills with a focus on developing and mentoring teams, and leading leaders.

Work Arrangement

This role is based in Belgium, Italy, Poland, UK or USA and requires on-site presence with flexibility for hybrid working arrangements.

Ready to make an impact? Apply today and join us in our mission to get ahead of disease together.

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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