Regulatory Affairs Officer
il y a 1 semaine
Belgium Life Sciences Brussels On-site
Ready to oversee regulatory compliance for diverse products?Join us as Regulatory Affairs Officer
- About The Member Company
- We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a fast-growing and proud community. We offer consultancy services to high-profile clients globally in diverse service areas, such as:
- Technology & Engineering
- Energy & Renewables
- Life sciences & Pharma
- Digital & IT
**About this vacancy**:
As Regulatory Affairs Officer, you are responsible for overseeing the regulatory aspects of various product categories e.g. food supplements, medicinal products, biocides, medical devices.
- You manage the regulatory activities for a diverse range of products, including but not limited to: prepare, submit and follow-up regulatory submissions (BLA, CTD, NDA, ), assess post-approval changes, manage responses to the Board of Health, review of packaging/inserts
- You collaborate closely with the Regulatory Affairs team and other departments.
- You act as the primary liaison with regulatory authorities and notified bodies.
- You act as a point of contact for regulatory audits, inspections and related processes.
- You are responsible for the regulatory impact assessment of changes and their implementation.
- You provide regulatory guidance for Research and Development (R&D) projects.
**What we expect from you**:
- You have a Master’s degree in Life Sciences.
- Experience with CMC is a plus.
- Relevant experience within Regulatory Affairs management and regulatory submissions is a plus.
- You have an eye for detail, strong communication and organization skills.
- Fluent in Dutch and English.
**What you can expect from us**:
TMC is an international high-tech consultancy company that brings expertise to its clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster-changing technological world.At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career. As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.
The 5 basic principles of **employeneurship**
- A long-term working relationship
- Enjoy the security of a long-term contract and a stable source of income while getting the opportunity to work at diverse projects.
- Individual profit sharing
- Full transparency. That’s it. For each of your projects, you know your hourly rate, your costs, and your individual performance-based profit sharing, all in order to stimulate your inner entrepreneur.
- Business cells
- Our employeneurs are grouped in business cells based on their technical expertise. They are small, focused and function as high-grade knowledge networks. And as buzzing communities of close colleagues.
- YOUniversity
- Every employeneur drives their own career. Together, we make a plan for personal and professional growth. Receive personal coaching and an extensive training budget to keep developing yourself and deliver outperformance at our clients.
- The Entrepreneurial Lab
- Work on your technical dreams in our lab. Collaborate with others in multidisciplinary teams to unlock out-of-the-box thinking and innovative ideas as well as entrepreneurial skills.
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