Regulatory Affairs Manager Benelux
- Experience Level
An exclusive, unique vacancy has arisen, for an experienced Regulatory Affairs Manager for Benelux, to join a fast-growing, medium-sized, global pharmaceutical company. This is an exciting time to join my client, a speciality and branded multinational organization, with a strong presence in Europe and over 70 established business operations across the world.
This position has a range of comprehensive accountabilities, is both strategic and operationally demanding with direct management responsibility, giving you maximum visibility within the business at a senior level. In addition, the position offers a high level of autonomy, giving you the opportunity to make positive changes and leave your own footprint managing projects from conception to completion.
This new expansion to the Regulatory Affairs team grants the opportunity to shape the role with autonomy, manage full accountability for regulatory submissions and related activities, create a strategy for the whole national landscape and drive the processes required in order to strengthen the Regulatory division.
- Managing regulatory submissions and lifecycle maintenance activities in accordance with the company’s strategy and in compliance with local regulations
- Leading the decentralisation regulatory submission process project from start to finish
- Direct Management of the Regulatory Affairs Officer
- Managing/preparing/reviewing marketing authorisations, completing submissions, variations, renewables and withdrawals
- Keep up to date with new developments and strategizing new regulatory plans
- Building and developing solid relationships with key international stakeholders and clients
- Working closely with Health Authorities both over the phone and face to face
- Be solutions-driven when leading and managing several complex projects in Regulatory Affairs
You will bring to the role:
- Bachelor’s degree or equivalent in Science, with an advanced degree being preferred
- Hands-on, relevant working experience with the pharmaceutical industry, including direct experience in regulatory affairs in the development
- Deep understanding and sound knowledge of regulations and guidelines concerning drugs and biologics in the development
- Experience supporting a portfolio of prescription medicine
- Confident in preparing or reviewing marketing authorisations, completing submissions, variations and withdrawals, by engaging directly with Health Authorities
My client will offer:
- Highly competitive salary plus bonus package
- Company car
- Competitive benefits package
- Flexibility with homeworking
- Excellent training and development plan with exciting career progression
- Full ownership of the regulatory function and the ability to work autonomously
If you have the skills and experience for this opportunity and the ambition to take on this position, please call Sophie for further details or email your CV today.
Contact Sophie at +44 1273 0596 49 or firstname.lastname@example.org
Sophie is a Search Consultant covering Europe, UK, North America and Asia.
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