Team Introduction:

We are seeking a highly motivated Regulatory Affairs Manager to join our team in Amersfoort!

You will be part of a diverse and energetic group of 7 colleagues, including a Regulatory Head, Regulatory Affairs Managers, and Pack Management Executives. Together, we work with passion and precision to ensure the registration and maintenance of products throughout their life cycle, while driving innovation and delivering excellence in everything we do.

As a key member of the team, you will play a vital role in managing the registration of new and registered products within your portfolio, ensuring compliance and supporting GSK’s mission to improve the lives of patients.

Do you have experience in Regulatory Affairs within a pharmaceutical environment? Are you ready to be part of an innovative company where your contributions truly make a difference?

If so, this might be the perfect role for you!

Job Purpose:

In this role, you’ll ensure our products meet regulatory requirements and are registered and maintained throughout their lifecycle. You’ll collaborate with cross-functional teams, including marketing, medical, market access, supply chain, quality, etc, to deliver business objectives. We value candidates who are detail-oriented, proactive, and passionate about driving compliance and innovation.

Key Responsibilities:

• Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with optimized registered Product Information and the correct alignment and compliance to regulations.
• Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and mitigation plans that are robust and aligned with business needs.
• Actively contribute to high performing teams, including looking for ways to improve performance. May lead cross-functional teams and regulatory professionals in the context of a project etc.
• Build relationships with key stakeholders and represent GSK in a responsible manner according to company values, in order to communicate GSK policies and strategies and negotiate outcomes.
• Manage compliance within defined portfolio/activity streams in line with GSK expectations - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements as well as CBG/MEB regulations). Propose solutions to identified issues and implement.
• Work together with Pack Management Executives to coordinate and approve final artwork and ensure packaging components are printed/produced in line with regulations, GSK expectations and commercial plans.
• Collaboratively working together with other functions (eg. medical, marketing, supply chain, QA) to help implement aRMMS, discontinuations and license withdrawals, to deliver company objectives and contribute to DHPC and product incidents/recalls.
• Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business.
• Maintain required high level of product knowledge within defined portfolio, regulatory compliance databases, systems and processes.

Why You?

Qualifications/Skills:

• Master’s or PhD in Pharmacy, Bio Medical/Life science/Pharmaceutically-related science (Chemistry, Biochemistry, (Medical) Biology, Medical Engineering).
• 3–5 years of experience in regulatory affairs within the pharmaceutical industry.
• Experience in maintenance of licences and registration of new products.
• Strong verbal and written communication skills in English and Dutch.
• Proven ability to manage complex assignments and meet deadlines.
• Analytical mindset with attention to detail and problem-solving skills.
• Experience with risk mitigation and process improvement.
• Experience with regulatory compliance databases and systems.
• Stakeholder management.

Work Environment:
This role is based in the Netherlands and offers a hybrid working model, combining on-site collaboration with remote flexibility.

Join us in shaping the future of healthcare while advancing your career in a supportive and innovative environment.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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 at https://openpaymentsdata.cms.gov/