Benelux Regulatory Manager
il y a 6 jours
About Haybury
We are a leading pharmaceutical company that seeks a Regulatory Affairs Specialist to drive business growth and operational excellence in the Benelux region.
This role combines strategic and operational responsibilities, with a focus on developing and executing regulatory plans, managing regulatory submissions, and ensuring compliance with local regulations.
Key Responsibilities:
- Manage regulatory submissions, lifecycle maintenance activities, and ensure compliance with local regulations.
- Prepare, review, and submit marketing authorizations, variations, renewals, and withdrawals.
- Develop and execute regulatory plans while staying updated on regulatory developments.
- Build strong relationships with key stakeholders, clients, and Health Authorities through regular communication and collaboration.
- Lead and manage multiple regulatory projects, ensuring timely and solutions-focused outcomes.
Requirements:
- MSc or PhD, or a BSc degree in a relevant field.
- Proven experience in Regulatory Affairs within the pharmaceutical industry, with a strong understanding of pharmaceutical quality systems, regulatory frameworks, and compliance standards.
- Expertise in managing prescription medicines and/or OTC products.
- Experience interacting with Health Authorities in the Benelux cluster.
- Full proficiency in Dutch and French is essential, as well as strong English communication skills.
- RIP accreditation (Responsible for Information and Publicity) is advantageous.
Benefits:
- A highly competitive salary and bonus package.
- Comprehensive benefits, including a hybrid working model.
- The chance to work autonomously and make a lasting impact within a forward-thinking organization.
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