Regulatory Affairs Manager

**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**:
**Key Responsibilities**:

- 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.

**Important notice to Employment businesses/ Agencies