Principal Regulatory Strategist (CRO / Pharma Industry)

MMS; Denver (CO); Remote; USD 120,000 - 180,000; Full time

Job summary

A leading clinical research organization seeks a Senior Regulatory Affairs specialist to provide consulting on regulatory matters and guide project teams. With at least 10 years in Regulatory Affairs, the ideal candidate will facilitate compliance, manage projects, and influence strategy. Join a supportive and innovative team dedicated to leading the future of clinical research.

Qualifications

• Minimum of 10 years experience in Regulatory Affairs or Strategy.
• Expert knowledge of regulatory principles and concepts.
• Hands-on experience with clinical trial and pharmaceutical development preferred.

Responsibilities

• Provide consulting and advisory services for complex regulatory issues.
• Author and maintain documentation for regulatory compliance.
• Conduct regulatory intelligence gathering and support regulatory roadmaps.

Skills

Facilities Management

Attorney

Computing

Cardiovascular

Analytics

Education

College graduate in Biological Science, Public Health, or Regulatory Science

Masters or PhD preferred

Tools

MS Office applications

Job description

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.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit 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.

Required Experience :

Senior IC

Key Skills

Facilities Management,Attorney,Computing,Cardiovascular,Account Opening,Analytics

Employment Type : Full-Time

Department / Functional Area : Regulatory Strategy

Experience : years

Vacancy : 1

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