Principal Regulatory Strategist (CRO / Pharma Industry) - Europe

MMS; Berlin; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

MMS, a leading clinical research organization, seeks a Principal Regulatory Strategist to provide expert regulatory consulting. The ideal candidate will have extensive experience in regulatory affairs, strong communication skills, and a relevant degree. This full-time remote role offers the chance to shape strategies and drive compliance within the industry.

Qualifikationen

• Minimum of 15 years’ experience in Regulatory Affairs or Strategy.
• Expert knowledge of scientific principles and concepts.
• Experience with Marketing Applications (EMA) is required.

Aufgaben

• Provide consulting and advisory services for complex regulatory issues.
• Author and maintain required documentation for regulatory compliance.
• Conduct regulatory intelligence gathering to support development of regulatory roadmaps.

Kenntnisse

Communication

Problem Solving

Organizational Skills

Ausbildung

College degree in Biological Science, Public Health, Regulatory Science

Masters or PhD preferred

Tools

MS Office

Jobbeschreibung

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO).

We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry-leading employee retention rate.

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges.

With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive.

Join us at MMS and be part of a team shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career.

Visit www.mmsholdings.com or follow MMS on LinkedIn.

This role is a full-time consultancy position, working remotely.

Principal Regulatory Strategist Responsibilities

1. Provide consulting and advisory services for complex regulatory issues or projects.
2. Author and maintain documentation required for regulatory compliance. Provide senior technical review for complex regulatory projects.
3. Conduct regulatory intelligence gathering to support development of regulatory roadmaps, feasibility assessments, and other reports.
4. Participate in project teams and provide expertise on regulatory matters.
5. Convey information clearly and accurately to peers, supervisors, and stakeholders.
6. Implement new or updated operational strategies to comply with policies and recommendations.
7. Identify new or updated policies and provide professional opinions on their impact to MMS and clients (via blogs, webinars, etc.).

Requirements

• College degree in Biological Science, Public Health, Regulatory Science, or related field; Masters or PhD preferred.
• Minimum of 15 years’ experience in Regulatory Affairs or Strategy, including experience with Marketing Applications (EMA).
• Expert knowledge of scientific principles and concepts; recognized as an emerging leader with sustained accomplishments.
• Proficiency with MS Office; clinical trial and pharmaceutical development experience preferred.
• Strong communication, problem-solving, organizational skills, and understanding of CROs, scientific data, and drug development processes.