MMS is hiring a
Principal Regulatory Strategist in United States

Summary

The job is for a Regulatory Affairs Consultant at MMS, a global CRO specializing in pharmaceutical, biotech, and medical device industries. The role involves providing consulting services, authoring regulatory documents, conducting regulatory intelligence, participating in project teams, and identifying new policies and recommendations.

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 and/or EMA) and FDA REMS
• Expert knowledge of scientific principles and concepts
• Reputation as emerging leader in field with sustained performance and accomplishment
• Proficiency with MS Office applications

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 implementation of new/updated operational strategies to comply with new/updated policies and recommendations

Preferred Qualifications

• Hands-on experience with clinical trial and pharmaceutical development preferred
• 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