Principal Regulatory Strategist

Summary

Join MMS, an award-winning, data-focused clinical research organization (CRO), and be part of a supportive, innovative team. We are a Great Place to Work certified organization with an exceptional culture and industry-best employee retention rate. We support pharmaceutical, biotech, and medical device industries. This is a full-time consultancy role, working remotely. As a Principal Regulatory Strategist, you will provide consulting and advisory services for complex regulatory issues, author and maintain documentation for compliance, and conduct regulatory intelligence gathering. You will participate in project teams, clearly convey information, and implement new operational strategies. You will also identify new policies and provide professional opinions on the impact of regulatory changes.

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 Affairs or Strategy or similar field required, including experience with Marketing Applications (EMA)
• Expert knowledge of scientific principles and concepts
• Reputation as emerging leader in field with sustained performance and accomplishment
• 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
• 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.)

Preferred Qualifications

Hands-on experience with clinical trial and pharmaceutical development preferred