Principal Regulatory Strategist CROPharma Industry - Europe

MMS; Málaga; A distancia; USD 120.000 - 150.000; Jornada completa

Descripción de la vacante

A leading clinical research organization is seeking a Principal Regulatory Strategist to provide expertise on complex regulatory issues. This full-time remote role requires a minimum of 15 years in Regulatory Affairs with strong communication skills and a collaborative mindset. Join a company recognized for its exceptional culture and innovative approaches in clinical research.

Formación

• 15+ years of experience in Regulatory Affairs or Strategy.
• Experience with EMA Marketing Applications.
• Knowledge of clinical trials and pharmaceutical development.

Responsabilidades

• Provide consulting and advisory services for regulatory issues.
• Author documentation for regulatory compliance.
• Conduct senior technical reviews for regulatory projects.
• Gather regulatory intelligence and support development of roadmaps.

Conocimientos

Extensive experience in Regulatory Affairs

Strong communication skills

Expertise in scientific principles

Proficiency with MS Office

Problem-solving skills

Educación

College degree in Biological Science or related field

Masters or PhD preferred

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 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 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 to ensure regulatory compliance.
• Conduct senior technical review for complex regulatory projects.
• Gather regulatory intelligence to support development of regulatory roadmaps, feasibility assessments, and reports.
• Participate on project teams, providing expertise on regulatory matters.
• Communicate clearly and accurately with peers, supervisors, and stakeholders.
• Implement operational strategies to comply with new policies and recommendations.
• Identify policy updates and provide professional opinions on regulatory changes impacting MMS and clients.

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, including experience with EMA Marketing Applications.
• Expert knowledge of scientific principles and concepts.
• Reputation as an emerging leader with sustained performance and accomplishments.
• Proficiency with MS Office applications.
• Experience with clinical trials and pharmaceutical development is preferred.
• Strong communication skills and collaborative mindset.
• Excellent problem-solving and organizational skills.
• Basic understanding of CROs, clinical data, terminology, and drug development process.

Required Experience

Senior IC

Key Skills

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

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