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Principal Regulatory Strategist (CRO Industry) - Remote

72% Flex
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Expert & Leadership (>10 years)
Work from: 
United States

Offer summary

Qualifications:

College graduate in Biological Science or related field, Minimum of 10 years' experience in Regulatory Affairs.

Key responsabilities:

  • Provide consulting and advisory services for regulatory issues.
  • Author and maintain necessary documentation for compliance.
  • Provide senior technical reviews for complex regulatory projects.
  • Conduct regulatory intelligence gathering to support development of roadmaps and feasibility assessments.
  • Participate in project teams and provide expertise on regulatory matters.
MMS logo
MMS SME https://www.mmsholdings.com
501 - 1000 Employees
About MMS
MMS is an award-winning, global clinical research organization (CRO) that supports leading pharmaceutical and biotech companies as well as many smaller enterprises across our spectrum of services. Having completed more than 50 submissions for drug approval over the last 5 years, we remain a top choice for sponsors who are looking for innovation and demand high quality from their CRO partners.Senior leadership at MMS has more than two decades of hands-on drug development experience which helps support program-level strategy and execution of projects across multiple therapeutic areas. Continual staff training, innovative recruitment and motivating career opportunities help MMS retain the best talent and develop a strong, client-focused workforce across all global locations.Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients'​ lives worldwide.
See more MMS offers

Job description

Logo Jobgether

Your missions

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

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.).
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.          
  • 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.

Required profile

Experience

Level of experience: Expert & Leadership (>10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Regulatory ComplianceMarketingFDA RegulationsMS Office

Soft Skills

  • Interpersonal Skills
  • Organizational Skills
Are you interested?

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