Vacancy: Regulatory affairs lead
What are your responsibilities?
- You are the lead of the internal regulatory professional team and are in the driver’s seat of regulatory policy and strategy for assigned projects
- As RA lead you attract multiple projects with different customers, you hold a helicopter view over these projects and steer the RA team in the concrete assignments. Occasionally giving training or doing an audit can also be part of it. Variety is key!
- The RA lead makes decisions regarding work processes or operational plans, follows budget allocations and keeps stakeholders informed on project resourcing
- You keep track of the?ever-changing legislation?in all the regions in which a company wishes to distribute its products and evaluate the impact on the business
- You align the operation of the departments with the realization of approved strategy, objectives and budget
- You?provide regulatory advice to project teams?to ensure continued regulatory compliance and timely market release.
- You work with?supra-national/international, national, and local regulatory agencies?(e.g. FAGG and FDA) on issues affecting drug research and development.
- You will work in companies within the 'life sciences': the?pharmaceutical, biotech, medical device, cosmetic and healthcare industries, ranging from the big pharma companies to the newest and most innovative start-up .
Who are we looking for?
- Master degree in life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer, …) or equivalent through experience
- 10+ experience in regulatory affairs in life sciences (knowledge of ISO 13485 is a plus) and with sterile production processes (in line with GMP Annex 1)
- You have proven 3-5 years in a leadership role with strong management skills. You have experience working in complex environments and with cross-functional teams.
- Profound knowledge of the relevant national and international legislation, procedural regulations and technical regulations.
- You have an eye for detail and excellent writing and communication skills (Dutch, English and French)
- You are result oriented, motivated and good at coordinating multiple projects and following up with internal/external stakeholders
- And finally, if the words accurate, driven, flexible and organized cover your personality, you are the perfect regulatory affairs (RA) lead.
What does QbD offer you?
QbD is a healthy company with a strong growth and international ambitions. In addition to a very attractive salary package, we can offer you the following advantages:
- Our CEO, Bart Van Acker, became Flemish Young Entrepreneur of 2019, which means that you’ll be part of a vibrant, entrepreneurial organization.
- A company with a clear strategy and ambition.
- We've got your back! Our HR Business Partners follow you closely, giving you the opportunity to shape your career.
- Thanks to our flat organization, we have short communication lines and you can always come to us.
- Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise.
- Get to know your colleagues outside the work environment! Teambuilding and fun activities?are planned on a monthly basis. A comedy night or quiz night? Nothing is too crazy for us!
- In short… We stand for JPEG:Joy in Partnership, going for the Extra mile to Get things done!
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!
Do you work as a self-employed person, but could you bring added value to our RA projects? We are also open to working with freelancers for exclusively project work within Regulatory Affairs (RA).