Regulatory & Safety Manager (all genders)
Job Id: 286099
Location: Hoeilaart, Flamande, Belgium
Job Type: Full-time
About the Role
We are seeking a Regulatory and Safety Manager to join our Belgian affiliate. In this role, you will serve as the local business partner for various stakeholders, managing both regulatory and pharmacovigilance (PV) aspects. You will be responsible for overseeing regulatory activities, including Health Authority interactions, ensuring the maintenance of Marketing Authorizations for the company's product portfolio. Your role will involve life cycle management of marketed products and registration of new compounds, including potential Early Access Programs for new assets. Additionally, you will foster strong relationships with Health Authorities.
As part of the Patient Safety Center BeNeLux, you will ensure the proper processing and follow-up of individual case safety reports from the Belgian market. You will also handle all PV-related requests from cross-functional teams, manage PV documentation, and act as the nominated person for PV towards the Belgian Health Authority. In collaboration with the Patient Safety Center Manager and the Global Organizations, you will ensure alignment with regulatory and safety policies across various cross-functional teams, including local management, QA, medical affairs, market access, and strategic partners.
Key Responsibilities
Manage regulatory activities to maintain Marketing Authorizations and oversee the registration of new compounds, including Early Access Programs.
Act as the primary point of contact for Health Authorities and maintain strong relationships.
Ensure appropriate processing and follow-up of individual case safety reports from the Belgian market.
Serve as the point of contact for all PV-related requests from cross-functional teams.
Maintain PV system documentation and act as the nominated person for PV towards the Belgian Health Authority.
Collaborate with local management, QA, medical affairs, market access, strategic partners, and business units.
Align with the Patient Safety Center Manager and Global Organizations to ensure compliance with local and global regulations.
Qualifications
Education: Master's degree in pharmacy or a related scientific subject.
Experience:
At least 4 years of experience in the pharmaceutical industry.
Strong technical regulatory knowledge of local regulatory requirements.
First experience with local/EU GVP requirements is valuable.
Experience in the review of promotional material is an asset.
Skills:
Strategic thinking and the ability to develop risk mitigation strategies.
Proficient in English and Dutch; French knowledge is an advantage.
Strong dedication and a high level of performance as a standout colleague.
What We Offer
We believe in fostering a diverse and inclusive culture that celebrates all dimensions of diversity. Our commitment to creating opportunities for personal growth and career advancement is central to our mission. Join us in a workplace that encourages innovation and supports human progress.
Apply now and become part of our diverse team!
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