Vacancy Life Sciences

Regulatory Affairs Specialist

In this position you support clients in mainly the pharmaceutical industry with the process of licensing and maintaining their products worldwide as a consultant.

| YOUR CHALLENGES?

• Providing Regulatory expertise for new product development and maintenance to ensure that regulatory requirements are compliant
• Developing/supporting regulatory strategies for new and existing products
• Having an important role in regulatory expert groups
• Staying up to date with the latest developments regarding your expertise
• Make sure other departments are up to date with relevant regulatory requirements
• Being able to answer questions from regulatory authorities
• Prepares and manages timely submissions of scientific dossiers for efficient licensing of new products and maintenance of existing products
• Ability to identify more complex (licensing) issues, analyze them, and provide possible solution

| WHAT DO WE EXPECT FROM YOU?

• BSc or Msc in Life Science / Pharma
• 3 years of work experience in relevant sector (pharmaceutical industry, medical devices)
• Ability to balance attention for detail with capacity to keep overview;
• Service and compliance minded
• Excellent command of the English language, Dutch preferred
• Team player skills

| WHAT DOES OUR BUSINESS CELL HAVE TO OFFER?

Our business cell lives by 3 principles:

1. Best over biggest.
2. Collaboration over individualism.
3. Values and ethics over rules.

| WHAT CAN YOU EXPECT FROM TMC?

TMC is an international high-tech consultancy company that brings expertise to their 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.

| WHY CHOOSE FOR EMPLOYENEURSHIP?

We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21th century for high skilled technical professionals. It is built around 5 main pillars:

• You will have a permanent employment contract, offering you stability and security
• You will get to know your market value and have a share in the profit your work generates thanks to the individual profit sharing
• We will support you with a one-on-one coaching and trainings designed to help you develop your entrepreneurial skills
• The competence cells structure, provides you with a strong meaningful and relevant network
• The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups

TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.