Principal Regulatory Strategist

Summary

Join MMS, an award-winning, data-focused CRO, and be part of a supportive, innovative team that values its employees. We offer a full-time, remote role providing consulting and advisory services for complex regulatory issues. We support pharmaceutical, biotech, and medical device industries. MMS maintains an industry-leading customer satisfaction rating and fosters a collaborative work environment. This position requires a minimum of 10 years of experience in Regulatory Affairs or Strategy, expert knowledge of regulatory principles, and strong leadership skills. Discover more about our exciting opportunities and why MMS is a great place to advance your career.

Requirements

• College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred
• Minimum of 10 years experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (FDA)
• Expert knowledge of regulatory principles and concepts
• Reputation as experienced leader with evidence of sustained performance and accomplishments
• Proficiency with MS Office applications
• 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 and scientific and clinical data/terminology, and the drug development process

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
• Provide cross-functional team leadership and management of multiple stakeholders across diverse projects
• Conduct regulatory intelligence gathering to support development of regulatory roadmaps, complex feasibility assessments, and other regulatory intelligence reports
• Participate in 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.)

Preferred Qualifications

Hands-on experience with clinical trial and pharmaceutical development preferred