Regulatory Affairs Specialist

About this vacancy

As a Regulatory Affairs Specialist in our Life Sciences & Med Tech team, you will work with regulatory strategy and compliance together with our clients in and around Gothenburg. The assignments can include regulatory submissions and dossiers, technical documentation, dialogue with authorities and notified bodies, regulatory intelligence and lifecycle management.

Assignments span pharmaceutical, biotechnology and medical device environments, and vary with the client and the phase of the product. Depending on the assignment, your work may include:

•       Authoring and reviewing regulatory submissions and dossiers, from pharmaceutical registration documentation to medical device technical documentation and premarket submissions.

•       Building regulatory strategy for market entry, product changes and lifecycle management across EU, US and other markets.

•       Preparing for and participating in dialogue with competent authorities and notified bodies.

•       Converting new regulatory guidance into concrete client recommendations, and maintaining regulatory intelligence.

•       Working across quality, clinical, R&D and commercial functions to keep submissions on schedule.

What we expect from you

We would be glad to see experience with FDA or EMA submission pathways, the European medical device and in vitro diagnostic regulations, premarket submissions, or regulatory documentation such as technical files and registration dossiers.

Requirements for the role:

•       An academic degree in life sciences, pharmacy, engineering or a comparable discipline.

•       Experience within regulatory affairs in the pharmaceutical, biotechnology or medical device industry.

•       Working command of at least one major regulatory framework within pharmaceuticals or medical devices.

•       Experience of preparing or reviewing regulatory submissions, or of interacting with regulatory authorities.

•       Strong communication skills, in writing and in dialogue.

•       English spoken and written fluently at a professional level. Swedish is considered a merit.

To fit this role, you will be proactive and have a strong drive and commitment. You enjoy taking assignments through to completion and have an analytical and strategic mindset. You are used to working in a dynamic environment and have experience communicating at different levels within larger organisations.

What you can expect from us

In the role as an Employeneur, you get to develop your technical expertise while also driving your own development and business. You become part of an innovative and entrepreneurial organisation where the focus is on continuous development and the opportunity to take full responsibility for steering your own career.

We place great importance on your personal commitment. You influence which projects you take on and which competence development you invest in. Quite simply, you steer your own career.

Since TMC is an international company, we can offer projects in the countries where we and our clients are present: Sweden, the Netherlands, Belgium, France, Luxembourg, Spain, Portugal, Italy, Hungary, U.A.E., the USA and Canada. The world is your workplace!

We are currently on holiday, but we look forward to handling your application in August when we are back.

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