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)
Skills Required
- University degree in a scientific or technical discipline
- Advanced degree
- Extensive experience in regulatory affairs and regulatory strategy
- Deep knowledge of German, Austrian, and European pharmaceutical regulations
- Knowledge of innovative medicines and vaccines, drug development, marketing authorization procedures, line extensions, and lifecycle management
- Working knowledge of artwork management systems, text-verification tools, and electronic document/data management systems
- Strategic thinking and sound regulatory judgment
- Critical thinking and problem-solving expertise
- Client-focused approach with consulting acumen
- Fluent German and English, written and verbal
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
