Regulatory Affairs Consultant – Germany & Austria (Munich on-site)

Parexel; Berlin; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Parexel is seeking an experienced Regulatory Affairs Professional to provide regulatory support for Germany and Austria, focusing on mRNA therapeutics and vaccines. This strategic role combines deep regulatory expertise with business acumen, and requires on-site presence in Munich at least one day per week.

The successful candidate will lead regulatory strategy, enable compliance, and collaborate with cross-functional teams to drive market access and lifecycle management across the two markets.

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, including medicines and vaccines 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).

Aufgaben

• Regulatory Strategy & Guidance: Deliver forward-looking, pragmatic regulatory guidance to affiliates and brand teams.
• Regulatory Compliance & Operations: Support local objectives via reviews, translations, artwork management, and market implementation activities.
• Stakeholder Management: Review materials and provide regulatory training to local teams; represent regulatory affairs in meetings.
• Market Access Support: Coordinate activities related to pricing, reimbursement, and tender processes.
• Authority Relations: Manage interactions with German/Austrian authorities for pipeline and licensed products.
• Project Leadership: Independently manage multiple regulatory projects in a fast-paced environment.
• Innovation & Efficiency: Explore AI and digital tools to enhance regulatory intelligence and workflows.
• Leadership Support: Deputise for the Director as needed.

Kenntnisse

Regulatory strategy

Regulatory operations

Stakeholder management

Project leadership

Generative AI

Leadership support

German language

English language

Ausbildung

Scientific/Technical degree

Advanced degree preferred

Tools

Artwork management systems

Text verification tools

Electronic document 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 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.

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)