Remote Regulatory Affairs Consultant - Switzerland & Germany na PAREXEL

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!

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)