GSK
Head, Vaccines Development Projects - CMC Regulatory Affairs
GSK, Collegeville, Pennsylvania, United States, 19426
Head, Vaccines Development Projects - CMC Regulatory Affairs
Join GSK as Head, Vaccines Development Projects - CMC Regulatory Affairs, 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.
Position Summary 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 life cycle and transition of CMC regulatory accountability to the mature products CMC regulatory department. You will lead the department accountable for delivering CMC strategy and advice for GSK’s vaccine development products, ensuring timely advice and strategy to project teams to secure regulatory approvals for clinical trials and marketing applications globally while complying with internal GSK processes, policies and regulatory requirements.
Responsibilities
Lead and oversee the development and execution of vaccine CMC regulatory strategies, ensuring alignment with GSK’s goals and regulatory requirements.
Establish and direct appropriate agency communications including End of Phase 2, Pre‑BLA, scientific advice, and ad‑hoc product‑specific agency dialogue.
Ensure risk assessments are conducted and appropriate mitigation and treatment plans are defined for product developments, liaising with Product Development, Commercial Supply Chain, GRA and other teams.
Provide appropriate GSK representation and input to product‑specific inspections for CMC aspects to secure approvals of new products and ensure continuous improvement.
Direct global teams that interface with CMC development and commercial supply organisations for GSK global development products, including in‑licensed assets.
Manage direct agency interface for CMC product‑specific aspects for all GSK development and in‑licensed assets and negotiate CMC agreements on behalf of R&D CMC development and Commercial Supply Chain.
Proactively manage budget and resource requirements for the department.
Liaise with heads of CMC regulatory development projects across modalities to drive aligned approaches for development and filings, and with the CMC RA mature products organisation to ensure an integrated regulatory strategy.
Manage, coach, and mentor staff across CMC RA.
Basic Qualifications
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 in diverse market environments and requirements, with proven ability to assimilate new and emerging requirements and establish optimized approaches in a 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
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 organisational 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, the UK or the 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 selection process, you can let us know the specific assistance you require 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, aiming to positively impact the health of 2.5 billion people by the end of the decade.
GSK does not accept referrals from employment businesses or agencies for vacancies posted on this site. All employment business or agency referrals must be authorized by GSK before submission.
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Position Summary 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 life cycle and transition of CMC regulatory accountability to the mature products CMC regulatory department. You will lead the department accountable for delivering CMC strategy and advice for GSK’s vaccine development products, ensuring timely advice and strategy to project teams to secure regulatory approvals for clinical trials and marketing applications globally while complying with internal GSK processes, policies and regulatory requirements.
Responsibilities
Lead and oversee the development and execution of vaccine CMC regulatory strategies, ensuring alignment with GSK’s goals and regulatory requirements.
Establish and direct appropriate agency communications including End of Phase 2, Pre‑BLA, scientific advice, and ad‑hoc product‑specific agency dialogue.
Ensure risk assessments are conducted and appropriate mitigation and treatment plans are defined for product developments, liaising with Product Development, Commercial Supply Chain, GRA and other teams.
Provide appropriate GSK representation and input to product‑specific inspections for CMC aspects to secure approvals of new products and ensure continuous improvement.
Direct global teams that interface with CMC development and commercial supply organisations for GSK global development products, including in‑licensed assets.
Manage direct agency interface for CMC product‑specific aspects for all GSK development and in‑licensed assets and negotiate CMC agreements on behalf of R&D CMC development and Commercial Supply Chain.
Proactively manage budget and resource requirements for the department.
Liaise with heads of CMC regulatory development projects across modalities to drive aligned approaches for development and filings, and with the CMC RA mature products organisation to ensure an integrated regulatory strategy.
Manage, coach, and mentor staff across CMC RA.
Basic Qualifications
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 in diverse market environments and requirements, with proven ability to assimilate new and emerging requirements and establish optimized approaches in a 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
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 organisational 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, the UK or the 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 selection process, you can let us know the specific assistance you require 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, aiming to positively impact the health of 2.5 billion people by the end of the decade.
GSK does not accept referrals from employment businesses or agencies for vacancies posted on this site. All employment business or agency referrals must be authorized by GSK before submission.
#J-18808-Ljbffr