Regulatory Manager, CMC Vaccines Development Projects

☞ GSK

Ver: 160

Día de actualización: 16-11-2025

Ubicación: Wavre Walloon Brabant

Categoría: Legales / Contratos Planificación / Proyectos Consultoría / Servicio al cliente

Industria: Pharmaceuticals

Tipo de empleo: Full-time

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Site Name: Belgium-Wavre, USA - Maryland - Rockville

Posted Date: Oct 21 2021

We are looking for a Regulatroy Manager to join the CMC team for Vaccines Development Projects.

Your Responsibilities
  • You drive the CMC strategy, coordinate the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development and registration of new vaccines or lifecycle activities and maintenance of registered vaccines, in accordance with the applicable regulatory & scientific standards, taking into account the evolving regulatory requirements.
  • You provide regulatory advice and guidance to the Technical Development Team and/or Technical Life-Cycle Team (TLCT), Implementation Committee, Specification Review Committee, Technical Review Board, CMC Expert Panel, and provides regulatory support to their partners in R&D, Quality Control, Manufacturing, QA and Supply.
  • You ensure adequate interaction and partnership with the Global Regulatory Lead’s team in order to define proper regulatory CMC filing strategy.
  • You ensure adequate contribution during interactions with Worldwide regulatory authorities.
  • You ensure, in a continuous improvement mindset, regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
  • You may engage and lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment).
  • You may mentor or train staff.
  • You may participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
  • You may deliver CMC regulatory strategy to support major inspections (eg PAI’s) or quality incidents (PIRCs).
Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:
  • Degree in Sciences or Medical Sciences (Chemistry, pharmacy, biological or closely related science)
  • Successfully managed multiple projects simultaneously.
  • Sound knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
  • Knowledge of CMC regulatory requirements.
  • Demonstrated ability to handle global CMC issues through continuous change and improvement
  • Fluent in English
Preferred Qualifications

If you have the following characteristics it would be a plus:
  • Regulatory Affairs Certification (e.g. RAPS).
  • Experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of leadership in a matrix environment.
  • Sound knowledge of vaccines/biological products development, manufacturing and supply processes.
  • Highly developed interpersonal, presentation and communication skills.
  • Experience in training staff within an organisation.
*Li-GSK VxRD*

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines – Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

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.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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.
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Plazo: 31-12-2025

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