Principal Regulatory Strategist (CRO Industry) - Europe, Remote Regulatory Affairs - Regulatory[...]

MMS Holdings Inc; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading clinical research organization in the City of London is seeking a Principal Regulatory Strategist to provide advisory services for complex regulatory issues. The ideal candidate will have a college degree in Biological Science or a related field, with a minimum of 15 years' experience in Regulatory Consulting. This role requires expert knowledge of regulatory principles and a proven ability to communicate effectively. Join our supportive team and become integral to advancing clinical research.

Qualifications

• Minimum of 15 years of experience in Regulatory Consulting or similar field.
• Expert knowledge of regulatory principles and concepts.
• Hands-on experience with clinical trial and pharmaceutical development preferred.

Responsibilities

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

Skills

Regulatory Consulting

Communication Skills

Problem-solving Skills

Organizational Skills

Education

College graduate in Biological Science, Public Health, or Regulatory Science

Masters or PhD preferred

Tools

MS Office applications

Job description

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 a 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 best 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.

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 conveys information to peers, supervisors, and other stakeholders.
• Participates in the implementation of new/updated operational strategies to comply with new/updated policies and recommendations.
• Identifies new/updated policies and recommendations and may provide professional opinions on impact of regulatory changes to MMS and Clients (from the desk of, blogs, webinars, etc.).
• Provides internal and cross-functional leadership and contributes to the development of robust processes and procedures when needed

Requirements

• College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.
• Minimum of 15 years’ experience in Regulatory Consulting (Affairs or Strategy) or similar field required, including experience with Marketing Applications (EMA).
• Expert knowledge of regulatory principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands‑on experience with clinical trial and pharmaceutical development preferred.
• Expert 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 CRO‑based consulting and scientific and clinical data/terminology, and the drug development process.

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.