Do you have experience in obtaining authorisations for medicinal products from European authorities?
Are you looking for an opportunity to develop regulatory plans in line with the business strategy?
Are you based in Almere, The Netherlands, or are you willing to relocate?
Fraser Dove International is working exclusively with an established pharmaceutical organisation specialising in pioneering cell therapies and new medicines. Operating worldwide, they are dedicated to becoming the world’s leading biopharmaceutical organisation.
Our client is seeking an innovative individual to maintain marketing authorisations in Europe for their medicinal products in alignment with European regulatory requirements.
Discover more about our Regulatory Affairs Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Regulatory Affairs Manager, you will be measured against the following objectives:
1) Maintaining and obtaining marketing authorisations in Europe in line with business strategies, needs and European regulatory requirements.
2) Developing and supporting regulatory strategies in line with the business plan.
3) Completing regulatory activities to ensure all regulatory obligations and business goals are met.
What you will do:
As the Regulatory Affairs Manager, your duties and responsibilities will include:
- Developing regulatory plans and strategies for implementation.
- Effectively pursuing approvals in accordance with regulatory requirements and business goals.
- Managing regulatory lifecycle and regulatory database of assigned products.
- Informing external partners of received marketing authorisation approvals.
- Reviewing and approving secondary packaging materials to ensure compliance with regulations.
- Cooperating with internal and external partners to maintain marketing authorisations.
- Providing relevant regulatory documentation for archiving to Regulatory Operations for assigned products.
- Informing staff of any safety-related concerns from regulatory bodies and changes accordingly.
- Staying up to date on current regulatory requirements.
What you will bring:
These are the skills and experience you will need to succeed as the Regulatory Affairs Manager:
- Strong work ethic and ability to work to tight deadlines.
- Ability to manage projects and prioritise appropriately.
- First-rate communication and presentation skills.
- Confident decision-maker and innovative thinker.
- Thorough understanding of medicines life cycle and the medicinal legislation of the EU.
- Minimum of two years’ experience in European medicinal product regulatory affairs.
- Bachelor’s degree in Pharmaceuticals, Chemicals or related Life Science subject.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Annual bonus of up to 15%.
- Private healthcare.
- Car/travel allowance.
- Generous holiday allowance.
- Free parking.
Got what it takes?
To apply for the Regulatory Affairs, click the ‘Apply’ button below or contact the Executive Search Consultant – Daniel Eastwood – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.