Director Regulatory Affairs: Vaccines, Biologics; development
- Employer
- NonStop Consulting
- Location
- Brussels, Belgium
- Salary
- car + package
- Start date
- 19 Feb 2021
- Closing date
- 26 Feb 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Senior Management
Job Details
My client, a large pharmaceutical company, is looking for their next Director of Regulatory Affairs to head their Vaccines & Biologics division.
As a part of the regulatory team, your role as director will be to properly coordinate all regulatory projects and make sure the RA division is running like a well-oiled machine.
Responsibilities include but are not limited to:
- Manage people in your team and for the assigned projects;
- Develop EU product regulatory strategy and optimise label, obtain shortest time to approval by regulatory agencies
- Develop product regulatory strategy for non-EU countries in the RAE region (CH and non-EU CES)
- Oversee the maintenance of all vaccines & biologicals in your assigned therapeutic area and be responsible for regulatory compliance of these products in the EU region;
- Responsible for all RA procedures in the region for the assigned projects and therapeutic area, including PIP applications, local and regional Scientific Advice, MRP, DCP, CP and national procedures
- Conduct due diligence licensing candidate review;
- Responsible for regulatory review and final approval of all submissions and associated documentation for the assigned vaccines/ biologicals;
- Provide support to the RA subsidiary team on subjects related to the projects or therapeutic area
- Provide EU expertise to the worldwide RA team, the product development teams and the Vaccines franchise;
- Be a recognised, internal expert (SME) for one or more aspects of regulatory policy and recognised as a scientific expert in one or more therapeutic areas.
Your ideal profile:
- Formal scientific background (Master's degree minimum in pharmaceutical sciences, biochemistry, etc...)
- At least 8-10 years of experience in Regulatory Affairs on Development level. Life Cycle Management experience strongly appreciated
- Previous experience with Vaccines/Biologics is required; experience with Infectious Diseases is a big plus
- Strong people management skills
- Strong negotiation skills (for contact with relevant authorities)
Company
NonStop Consulting is an international recruitment consultancy renowned for a high level of service, professionalism, unrivalled industry knowledge and extensive industry networks.
With over 100 multilingual recruiters covering the life sciences industry across Europe, we take the time to get to know you – your wants, needs and aspirations. We then work tirelessly to match you with an employer that both matches your requirements and is the right cultural fit for you.
Underpinned by our in-house Quality Assurance team, our relationship with job seekers is fully transparent and truly consultative. Our recruitment consultants pay attention to every detail and pride themselves on being open and honest, ensuring the right opportunities for you as well as valuable feedback.
We are active members of APSCo, the Association of Professional Staffing Companies – a recognised badge of quality with the recruitment industry.
If you want to find out more about how we can help you, get in touch!
- Website
- https://nonstopconsulting.com/en/
- Telephone
- +41 (0) 435 080 817
- Location
-
24 Poststrasse
Zug
6300
United Kingdom
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