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Principal Regulatory Strategist

2 weeks ago

Cork, Cork, Ireland Mms Full time

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS 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  or follow MMS on LinkedIn .
Principal Regulatory Strategist 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 15 years' experience in Regulatory Affairs or Strategy or similar field required, including experience with Marketing Applications (EMA).
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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