Principal Regulatory Strategist CROPharma Industry - Europe

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

Descripción de la vacante

A leading clinical research organization based in Valencia is seeking a Principal Regulatory Strategist. In this remote full-time consultancy role, you will provide consulting and advisory services, conduct regulatory intelligence gathering, and maintain documentation to ensure compliance. The ideal candidate will have at least 15 years of experience in Regulatory Affairs, with an academic background in Biological Science or a related field. Join a supportive and innovative team that values your contributions.

Formación

• Minimum of 15 years experience in Regulatory Affairs or Strategy.
• Expert knowledge of scientific principles and concepts.
• Hands-on experience with clinical trials and pharmaceutical development preferred.

Responsabilidades

• Provide consulting and advisory services for complex regulatory issues.
• Author and maintain documentation for regulatory compliance.
• Conduct regulatory intelligence gathering.

Conocimientos

Regulatory Affairs expertise

Communication skills

Problem solving

Organizational skills

Collaboration

Educación

College graduate in Biological Science, Public Health, Regulatory Science

Masters or PhD preferred

Herramientas

MS Office applications

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 or follow MMS on LinkedIn.

This would be a full-time consultancy role working remotely.

Principal Regulatory Strategist Responsibilities

• Provide consulting and advisory services for complex regulatory issues or projects.
• Author and maintain documentation as required to sustain regulatory compliance.
• Provide senior technical review for complex regulatory projects.
• Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports.
• Participate on project teams and provide expertise on related regulatory matters.
• Clearly and accurately convey information to peers, supervisors, and other stakeholders.
• Participate in the implementation of new / updated operational strategies to comply with new / updated policies and recommendations.
• 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

• College graduate in Biological Science, Public Health, Regulatory Science, or related field; Masters or PhD preferred.
• Minimum of 15 years experience in Regulatory Affairs or Strategy or similar field, including experience with Marketing Applications (EMA).
• Expert knowledge of scientific principles and concepts.
• Reputation as an emerging leader in the field with sustained performance and accomplishments.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trials and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• 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