Principal Regulatory Strategist (CRO Industry) Europe, Remote

Are you looking to join a company where your contributions truly matter and where youll be part of a supportive innovative teamMMS 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.

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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 in 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

• College graduate in Biological Science Public Health or Regulatory Science or related field or related experience Masters or PhD preferred.
• Minimum of 15years experience inRegulatory Consulting (Affairs or Strategy)or similar field required including experience with Marketing Applications (EMA).
• Expert knowledge ofregulatoryprinciples 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 consultingand scientific andclinical data/terminology andthe drug development process.