Regulatory & Safety Manager (RIP qualified) 1 at Merck Sharp & Dohme Corp. /Netherlands

Hoeilaart, Flanders, Belgium -

Full Time

Start Date

Immediate

Expiry Date

13 Feb, 26

Salary

0.0

Posted On

15 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Pharmacovigilance, Health Authority Interactions, Marketing Authorizations, Life Cycle Management, Early Access Programs, Patient Safety, Cross-Functional Collaboration, Strategic Thinking, Risk Mitigation, English Proficiency, Dutch Proficiency, Dedication, Willingness to Perform

Industry

Pharmaceutical Manufacturing

Description

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. You are open to obtain a RIP (Responsible Person for Information and Publicity) qualification. You have a demonstrated experience within regulatory affairs 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! Apply now and become a part of our diverse team!

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Responsibilities

You will act as the local Business partner for Regulatory and Pharmacovigilance aspects, ensuring maintenance of Marketing Authorizations and managing the life cycle of marketed products. You will also process individual case safety reports and maintain documentation for the PV system while collaborating with various teams.