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

Parexel International; München; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Parexel International seeks an experienced Regulatory Affairs Professional to support Germany and Austria, including mRNA therapeutics and vaccines. The role requires on-site presence in Munich at least one day per week, with strategic regulatory leadership across multiple projects.

You will guide regulatory strategy, ensure compliance, and collaborate with cross-functional teams, vendors, and authorities to enable market access and lifecycle management in a fast-paced environment.

Qualifikationen

• University or scientific/technical degree; advanced degree preferred.
• Extensive experience in regulatory affairs and regulatory strategy.
• Deep knowledge of German, Austrian, and European pharmaceutical regulations, incl. medicines and vaccines lifecycle.
• Strong working knowledge of regulatory systems and tools (artwork management, text verification, electronic document/data management).
• Strategic thinking with sound regulatory judgment.
• Critical thinking and problem-solving skills.
• Client-focused consultancy mindset.
• Fluent in German and English (written and spoken).

Aufgaben

• Provide regulatory strategy and guidance to affiliate and brand teams.
• Coordinate regulatory compliance, translations, artwork management, and market implementation activities.
• Review promotional materials and medical communications; deliver regulatory training and updates to local teams.
• Coordinate pricing, reimbursement, and tender-related regulatory activities for market access.
• Manage interactions with German and Austrian authorities for pipeline and licensed products.
• Lead multiple complex regulatory projects with precision, compliance, and strategic judgment.
• Explore Generative AI and digital tools to enhance regulatory workflows and efficiency.
• Deputise for the Director, Regulatory Affairs Strategy as needed.

Kenntnisse

Regulatory strategy

Regulatory compliance

Stakeholder management

Market access

Authority relations

Project leadership

Innovation

Leadership support

Ausbildung

Advanced degree preferred

Tools

Artwork management systems

Text verification tools

Electronic document management systems

Jobbeschreibung

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)