Principal Regulatory Strategist (CRO/Pharma Industry) - Remote

MMS Holdings Inc; Michigan; Remote; USD 100,000 - 130,000; Full time

Job summary

MMS Holdings Inc is seeking a seasoned professional for a full-time remote role in Regulatory Affairs. The position focuses on providing regulatory consulting and leadership, requiring deep expertise and a minimum of 10 years of experience in the field. Join a supportive and innovative team committed to excellence in clinical research.

Qualifications

• 10+ years experience in Regulatory Affairs or Strategy required.
• Expert knowledge of regulatory principles.
• Experience with clinical trials and drug development preferred.

Responsibilities

• Provide consulting and advisory services for regulatory issues.
• Author and maintain documentation for regulatory compliance.
• Lead cross-functional teams across diverse projects.

Skills

Communication

Problem-Solving

Organizational Skills

Education

College degree in Biological Science, Public Health, Regulatory Science or related field

Masters or PhD preferred

Tools

MS Office

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.comor follow MMS on LinkedIn.

This would be a full-time role, working remotely.

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.).

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.
• 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 andclinical data/terminology, andthe drug development process.