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

Parexel; Deutschland; Vor Ort; EUR 85.000 - 125.000; Vollzeit

Zusammenfassung

Parexel is seeking an experienced Regulatory Affairs Professional to provide comprehensive regulatory support for Germany and Austria. This strategic role combines deep regulatory expertise with business acumen to support mRNA therapeutics and vaccines across the region.

The role requires on-site presence at least one day per week at the Munich office, with responsibility for regulatory strategy, compliance, market access coordination, and stakeholder management across affiliate teams.

Qualifikationen

• Advanced degree preferred in a scientific or technical field.
• Extensive 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

• Regulatory Strategy & Guidance: deliver strategic regulatory guidance to teams and anticipate challenges.
• Regulatory Compliance & Operations: coordinate reviews, translations, artwork management, and market implementation.
• Stakeholder Management: review materials, provide regulatory training, represent RA in meetings.
• Market Access Support: coordinate activities related to pricing, reimbursement, and tenders.
• Authority Relations: manage interactions with German and Austrian authorities for pipeline and products.
• Project Leadership: manage multiple complex regulatory projects in a fast-paced environment.
• Innovation & Efficiency: explore Generative AI and digital tools to improve workflows.
• Leadership Support: deputise for the Director, Regulatory Affairs Strategy – Germany and Austria as needed.

Kenntnisse

Regulatory affairs

Regulatory strategy

German language

English language

Project leadership

Stakeholder management

Ausbildung

Science/Technical degree

Tools

Artwork management systems

Jobbeschreibung

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.

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)