Principal Regulatory Strategist CROPharma Industry - Europe

MMS; Madrid; A distancia; EUR 80.000 - 120.000; Jornada completa

Descripción de la vacante

Join a forward-thinking clinical research organization as a Principal Regulatory Strategist. In this full-time remote role, you'll provide consulting and advisory services for complex regulatory challenges, author documentation for compliance, and contribute to regulatory intelligence efforts. With a commitment to innovation and a supportive team environment, this position offers the chance to shape the future of clinical research while working with industry leaders. If you have extensive experience in Regulatory Affairs and a passion for problem-solving, this opportunity is perfect for you.

Formación

• 15+ years in Regulatory Affairs or Strategy, including Marketing Applications.
• Expert knowledge of scientific principles and regulatory compliance.

Responsabilidades

• Provide consulting for complex regulatory issues and author required documentation.
• Conduct regulatory intelligence gathering and participate in project teams.

Conocimientos

Regulatory Affairs

Problem-solving

Communication Skills

MS Office Proficiency

Clinical Trials Experience

Scientific Principles Knowledge

Educación

Bachelor in Biological Science

Master's or PhD in related field

Herramientas

MS Office

Descripción del empleo

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 not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is 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 would be a full-time consultancy role working remotely.

Principal Regulatory Strategist

Responsibilities

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

Requirements

1. College graduate in Biological Science, Public Health, Regulatory Science, or related field; Masters or PhD preferred.
2. Minimum of 15 years experience in Regulatory Affairs or Strategy or similar field, including experience with Marketing Applications (EMA).
3. Expert knowledge of scientific principles and concepts.
4. Reputation as an emerging leader in the field with sustained performance and accomplishments.
5. Proficiency with MS Office applications.
6. Hands-on experience with clinical trials and pharmaceutical development preferred.
7. Good communication skills and willingness to work with others to clearly understand needs and solve problems.
8. Excellent problem-solving skills.
9. Good organizational and communication skills.
10. Basic understanding of CROs, scientific and clinical data/terminology, and the drug development process.

Required Experience: Senior IC

Key Skills

Facilities Management, Attorney, Computing, Cardiovascular, Account Opening, Analytics