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Regulatory Affairs Consultant - Switzerland & Germany

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
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Offer summary

Qualifications:

University degree in a scientific area, Several years of experience in regulatory affairs.

Key responsabilities:

  • Provide strategic guidance on regulatory requirements
  • Support national dossier filings and centralized dossier preparation
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Parexel XLarge http://www.parexel.com
10001 Employees
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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)

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Detail Oriented
  • Teamwork
  • Problem Solving

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