Regulatory Affairs Consultant
Regulatory affairs ensure that its organization complies with all the regulations and laws pertaining to drug and medical devices research and development companies. RA works with supra-national/international, national, and local regulatory agencies (e.g. FAGG and FDA) on issues affecting drug research and development.
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 maintain contacts with the agency’s staff and notify them when new regulations are published
- 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
- The presentation of registration documents to regulatory agencies
WHO ARE WE LOOKING FOR?
- Master degree in life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer, …) or equivalent through experience
- First 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 fully understand the regulatory compliance in your field and you have good knowledge of quality system (QMS) requirements
- Experience of working in cross-functional teams
- You have an eye for detail and excellent writing and communication skills
- You master good organizational skills with a pragmatic, hands-on and flexible approach to your work
- You are able to find a good balance between critical mindset and practical approach.
- 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?
- A young, dynamic company with a let’s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
- Personal and professional development through guidance, education and knowledge sharing
- A competence development model focused on your personal ambitions
- An attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.