Parexel
Regulatory Affairs Consultant – Germany & Austria (Munich on-site) m/f/d
Germany · Work style not stated · Full time
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About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerParexel
- LocationGermany
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
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.
About the Role
We are seeking an experiencedRegulatory Affairs Professional to provide comprehensive regulatory support for Germany and Austria. This is a strategic role that combines deep regulatory expertise with business acumen, supporting our client's mRNA therapeutics and vaccines across Germany and Austria.
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This role requires at least one day per week on-site presence (the office is in Munich).
Key Responsibilities
Regulatory Strategy & Guidance: Deliver forward-looking, pragmatic, and creative strategic regulatory guidance to affiliate and brand teams, anticipating regulatory challenges and providing agile solutions
Regulatory Compliance & Operations: Support local business objectives through coordination of cross-functional reviews, translations of product information, artwork management, and market implementation activities
Stakeholder Management: Review promotional materials and medical communications; provide regulatory training and updates to local affiliate teams; represent the Regulatory Affairs team in internal, affiliate, and cross-functional meetings
Market Access Support: Coordinate regulatory activities related to pricing, reimbursement, and tender processes
Authority Relations: Manage and coordinate interactions with German and Austrian regulatory authorities concerning client's pipeline and licensed products
Project Leadership: Independently manage multiple complex regulatory projects in a fast-paced environment while maintaining precision, compliance, and strategic judgment
Innovation & Efficiency: Explore opportunities to leverage Generative AI and emerging digital capabilities to enhance regulatory intelligence, content workflows, and operational efficiency
Leadership Support: Deputise for the Director, Regulatory Affairs Strategy – Germany and Austria as needed
Required Skills and Qualifications:
University Degree in a Scientific or Technical Discipline (Advanced Degree preferred)
Extensive years of experiencein regulatory affairs and regulatory strategy
Deep knowledge of German, Austrian, and European pharmaceutical regulations, including: innovative medicines and vaccines, drug development and marketing authorisation procedures, line extensions and lifecycle management
Strong working knowledge of regulatory systems and tools (artwork management systems, text-verification tools, electronic document/data management systems)
Strategic thinking and sound regulatory judgment
Critical thinking and problem-solving expertise
Client-focused approach with consulting acumen
Fluent in German and English(written and verbal)
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At a glance
- Employment typeFull time
- Employer posted
- Added to ROLIVA
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Skills in this posting
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