Senior Manager, GRA CMC Vx Mature Product

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.

Find out more: Our approach to R&D

Locations: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland

Scope

This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you'll work closely with cross-functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail-oriented, and skilled at navigating complex regulatory environments.

In this role, you will:

• Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with global standards.
• Prepare and review technical regulatory documents to support submissions and lifecycle management.
• Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance.
• Lead discussions with regulatory authorities and represent the company in external engagements.
• Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
• Mentor and train team members, fostering a culture of continuous improvement.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in life sciences, pharmacy, chemistry, or a related field.
• Solid and proven experience in CMC regulatory affairs.
• Strong knowledge of global CMC regulatory requirements and drug development processes.
• Proven ability to manage multiple projects and meet deadlines.
• Must be fluent in English (both written and spoken).

Preferred Qualifications:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Master's degree or PhD in a relevant scientific discipline.
• Regulatory Affairs Certification (e.g., RAPS).
• Experience leading teams and managing complex regulatory submissions.
• Track record of effective negotiation with regulatory agencies.
• Excellent communication and collaboration skills.
• Proficiency in French is a plus.

Please note that relocation support cannot be provided; therefore, only candidates who are already based in the indicated country can be considered.

Closing Date for Applications – 9 November 2025

I candidati interni interessati alla posizione possono applicare attraverso la sezione My Job Opportunities in Workday entro il 9 novembre 2025 COB . Secondo la Policy GSK, questo Job Posting è aperto a tutti i dipendenti a tempo indeterminato e determinato GSK ed ai lavoratori in somministrazione e CW presso GSK Italia. Le domande saranno prese in considerazione solo se il candidato è nella posizione corrente da almeno 12 mesi. Saranno accettate esclusivamente candidature pervenute tramite Workday.

L'inquadramento offerto rispecchierà l'effettiva competenza ed esperienza maturate dal candidato identificato, in relazione alle responsabilità del ruolo proposto.

Ricordiamo che è necessario informare il proprio responsabile nel momento in cui si viene convocati per il colloquio di selezione.

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

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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.

Find out more: Our approach to R&D

Locations: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland

Scope

This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you'll work closely with cross-functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail-oriented, and skilled at navigating complex regulatory environments.

In this role, you will:

• Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with global standards.
• Prepare and review technical regulatory documents to support submissions and lifecycle management.
• Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance.
• Lead discussions with regulatory authorities and represent the company in external engagements.
• Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
• Mentor and train team members, fostering a culture of continuous improvement.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in life sciences, pharmacy, chemistry, or a related field.
• Solid and proven experience in CMC regulatory affairs.
• Strong knowledge of global CMC regulatory requirements and drug development processes.
• Proven ability to manage multiple projects and meet deadlines.
• Must be fluent in English (both written and spoken).

Preferred Qualifications:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Master's degree or PhD in a relevant scientific discipline.
• Regulatory Affairs Certification (e.g., RAPS).
• Experience leading teams and managing complex regulatory submissions.
• Track record of effective negotiation with regulatory agencies.
• Excellent communication and collaboration skills.
• Proficiency in French is a plus.

What We Offer:

• Permanent contract in a very Inclusive environment
• Smart Working up to 50% for eligible roles
• Performance Reward
• Flexible Benefits
• Company Healthcare Plan
• Integrative pension fund
• Employee Assistance Programme
• Prevention services and vaccination clinic
• Tax assistance
• Local nursery agreement
• Postal service, laundry, shoe repair and tailoring
• On Site Gym
• On Site canteens and coffee corners
• Free company bikes and shuttle

Closing Date for Applications – 9 November 2025

Please note that relocation support cannot be provided; therefore, only candidates who are already based in the indicated country can be considered.

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

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

#LI-Hybrid

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website

---