Regulatory Affairs Consultant - Switzerland & Germany
Switzerland, Remote Additional Locations: Berlin, Berlin, Germany Job ID R0000027369 Category Regulatory / Consulting Date Posted 09/10/2024Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
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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