Principal Regulatory Strategist

2 weeks ago

Pittsburgh, United States MMS Full time
Job DescriptionJob DescriptionMMS 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.

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