Regulatory Affairs Consultant – Germany & Austria (Munich on-site) m/f/d

Parexel International, LLC; München; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Parexel International, LLC is seeking an experienced Regulatory Affairs Professional to support Germany and Austria. The role combines deep regulatory expertise with business acumen to support mRNA therapeutics and vaccines across the region.

It requires at least one day per week on-site in Munich and engagement with multiple stakeholders across affiliate and functional teams. Ideal candidates will have a university degree in a scientific or technical discipline, extensive regulatory experience,

Qualifikationen

• University Degree in a Scientific or Technical Discipline (Advanced Degree preferred).
• Extensive years of experience in regulatory affairs and regulatory strategy.
• Deep knowledge of German, Austrian, and European pharmaceutical regulations.
• Fluent in German and English (written and verbal).

Aufgaben

• Deliver strategic regulatory guidance to affiliate and brand teams.
• Coordinate reviews, translations, artwork management, and market implementation activities.
• Review promotional materials and provide regulatory training to local teams.
• Coordinate regulatory activities related to pricing, reimbursement, and tender processes.
• Manage interactions with German and Austrian regulatory authorities.
• Independently manage multiple complex regulatory projects.
• Explore opportunities to leverage AI and digital tools to improve workflows.

Kenntnisse

Regulatory strategy

German regulatory knowledge

English proficiency

Stakeholder management

Project leadership

Ausbildung

University degree in a scientific/technical discipline

Tools

Artwork management systems

Text verification tools

EDM systems

Jobbeschreibung

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 experienced Regulatory 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.

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 experience in 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)