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    Principal Regulatory Strategist - Phoenix, United States - MMS

    MMS
    MMS Phoenix, United States

    2 weeks ago

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    Description

    Job Description

    Job 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 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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