Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role
Ready to join our Belgian affiliate? We are looking for a Regulatory and Safety Manager. You will perform as the local Business partner to different stakeholders of the local organization for Regulatory and Pharmacovigilance (PV) aspects. An outstanding possibility, combining the expertise of both. You will be responsible for key regulatory activity, including any required Health Authority interactions for our organization, to ensure maintenance of Marketing Authorizations for the company's product portfolio. Tasks will be the life cycle management of the marketed product as well as registration of new compounds, including possible Early Access Programs for new assets. You will act as a point of contact for Health Authorities to maintain close relationships.
The PV activities in Belgium are embedded in the Patient Safety Center BeNeLux. You will ensure that individual case safety reports from the Belgian market are appropriately processed and followed up. You are the contact point for all PV-related requests from cross-functions. You maintain the vital documentation of the PV system and act as the nominated person for PV towards the Belgian Health Authority. You will report within the Regulatory organization with a close alignment of the Patient Safety Center Manager. Further, you will collaborate closely with the Global Organizations as well as the cross-functional teams (local Management, QA, Medical Affairs, Market Access, strategic partners, Business Unit).
Who you are
- You completed a master’s degree in pharmacy or have a degree as a medical doctor.
RIP (Responsible Person for Information and Publicity) qualification would be necessary.
- You have at demonstrated experience in the pharmaceutical industry and have the technical regulatory knowledge of local regulatory requirements (First experience with local / EU GVP requirements is valuable).
- You understand business needs, think strategically, and develop risk mitigation strategies.
- Excellent English and Dutch knowledge is necessary.
- You are a standout colleague with a high level of dedication and a strong willingness to perform.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
and become a part of our diverse team!
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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