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Regulatory Affairs Consultant - Switzerland & Germany

, Remote Date posted 09/10/2024 Job ID R0000027369

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker
  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access
  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

Are you a fluent German speaker with expertise in regulatory affairs? Do you have a passion for navigating the complex world of pharmaceutical regulations in Germany, Switzerland, and the EU? We are seeking a talented and experienced Regulatory Affairs Consultant to join our dynamic team!

The role can be home or office based in various European locations.

Key Responsibilities:

  • Provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland

  • Support national dossier filings and contribute to centralized dossier preparation

  • Offer expert advice on new product applications and lifecycle maintenance

  • Lead small-scale projects or work streams, ensuring client satisfaction and project success

  • Collaborate with cross-functional teams to deliver high-quality regulatory solutions

Ideal Candidate Profile:

  • University degree in a scientific area

  • Several years of experience in regulatory affairs, specifically in German and Swiss markets

  • Experience working with Swissmedic and BfArM

  • In-depth knowledge of international regulatory requirements

  • Strong understanding of EU regulatory landscape

  • Excellent project management and client communication skills

  • Ability to work independently and as part of a team

  • Proactive problem-solver with keen attention to detail

  • Fluent English and German speaker (required)


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