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. Powered by JazzHR
Principal Regulatory Strategist (CRO Industry) - Remote
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