Vacancy: Regulatory affairs consultant
Do you want to ensure that the organization complies with all the regulations and laws pertaining to drug and medical devices research and development companies? Are you accurate, driven, flexible and organized? Then you are the perfect RA specialist!
What are your responsibilities?
- You guarantee that the legal requirements regarding (inter)national laws and company standards are met.
- 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 carry out all negotiations necessary to obtain and maintain a marketing authorization for the products concerned, anticipating the product release.
- You provide regulatory advice to project teams to ensure continued regulatory compliance and timely market release.
- You advise on the legal and scientific restraints and requirements, while collecting and evaluating scientific data.
- You supervise the exchange and presentation of the registration documents to regulatory agencies.
- You work with supra-national/international, national, and local regulatory agencies (e.g. FAGG and FDA) on issues affecting drug research and development.
- You offer support during product launch: developing marketing materials, product registration, … After launch you are involved in post market surveillance tasks and handling of adverse events.
Who are we looking for?
- You have a scientific master’s degree (e.g. industrial pharmacist, biomedical sciences, bio-engineer, …) or equivalent through experience.
- You have experience in regulatory affairs in the life sciences industry (knowledge of ISO 13485 is a plus) or with sterile production processes (in line with GMP Annex 1).
- You have profound knowledge of the relevant national and international legislation, procedural regulations and technical regulations.
- As an experienced consultant you feel comfortable taking care of the early stage considerations and the development of regulatory plans.
- You like to work in cross-functional teams and have good people management skills.
- 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 specialist.
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 RA.