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

Parexel; Deutschland; On-site; EUR 100,000 - 160,000; Full time

Benefits offered by this job

On-site Munich office

Job summary

Parexel International seeks an experienced Regulatory Affairs Professional to support regulatory activities for Germany and Austria, focusing on mRNA therapeutics and vaccines. This role combines regulatory expertise with business insight across two countries.

The position requires at least one day per week on-site in Munich, with responsibilities spanning strategy, compliance, stakeholder training, market access support, and authority interactions.

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.
• Strong working knowledge of regulatory systems and tools (artwork management, text verification, and data management).
• Strategic thinking and regulatory judgment.
• Client-focused consulting acumen.
• Fluent in German and English (written and spoken).

Responsibilities

• Deliver regulatory strategy & guidance to affiliates and brand teams; anticipate challenges with agile solutions.
• Coordinate regulatory compliance and operations with cross-functional reviews and translation of product information.
• Review promotional materials and medical communications; provide regulatory training to affiliates.
• Coordinate regulatory activities for pricing, reimbursement, and tender processes.
• Manage interactions with German and Austrian authorities for pipeline and licensed products.
• Independently lead multiple complex regulatory projects in a fast-paced environment.
• Explore AI and digital tools to enhance regulatory intelligence and workflows.
• Deputise for the Director, Regulatory Affairs Strategy – Germany and Austria as needed.

Skills

Regulatory strategy

Regulatory compliance

Stakeholder management

Leadership

German & English fluency

Regulatory knowledge (EU/DE/AU)

Education

University degree in science/tech

Advanced degree preferred

Tools

Artwork management systems

Text-verification tools

Document management systems

Job description

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)

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