Principal Regulatory Strategist

3 weeks ago

Raleigh, 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.

Powered by JazzHR

PQ8IPlPfpn

  • Principal Engineer

    4 weeks ago

    Raleigh, North Carolina, United States Merz North America Inc Full time

    The Principal Transducer Engineer will lead ultrasound transducer projects through the product development process from feasibility and prototype building through verification and transfer to production. The engineer will be responsible for transducer design efforts in house as well as managing external design partners. Responsible for providing cross...

  • Principal Mechanical Engineer

    2 weeks ago

    Raleigh, United States Merz North America Full time

    Principal mechanical engineers develop new products, redesign existing products, and perform research and testing on product concepts related to medical devices. This individual will be an important member of the Merz Advanced Development team focused on research, development, and bringing to market medical devices to support Merz business objectives. The...

  • Principal Mechanical Engineer

    4 days ago

    Raleigh, United States Merz North America Full time

    Principal mechanical engineers develop new products, redesign existing products, and perform research and testing on product concepts related to medical devices. This individual will be an important member of the Merz Advanced Development team focused on research, development, and bringing to market medical devices to support Merz business objectives. The...

  • Senior Principal Engineer

    7 days ago

    Raleigh, United States Hazen and Sawyer Full time

    Seeking Professional Licensed Engineer with 5 - 15 years of experience in the water industry. Background and experience in municipal or industrial water, wastewater, reclaimed water, stormwater, detailed design, utility management, operations and maintenance, and/or program management are desired. Hazen and Sawyer is a stable, growing, employee-owned company...

  • Principal Clinical Data Manager

    2 weeks ago

    Raleigh, United States Biodata Partners, Inc. Full time

    Job DescriptionJob DescriptionJob Summary:Manage end-to-end delivery of data management services concurrently for single/multi-service projects with little-to-no guidance, ensuring quality deliverables on time and within budget to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high...

  • Director Wealth Financial Operations

    4 weeks ago

    Raleigh, United States CareerBuilder Full time

    Overview This position is responsible for all finance functions within the Wealth Management department of the Bank. Oversees functions including First Citizens Investor Services Broker/Dealer and RIA, First Citizens Asset Management RIA, SVB Wealth, LLC, Private Wealth Advisory Services, Institutional Advisory Services, and the Private Client Group. Ensures...

  • HRBP Audit Associate Director

    2 weeks ago

    Raleigh, United States Grant Thornton International Full time

    Grant Thornton is seeking a HRBP Associate Director to join the team in Charlotte, NC. The Human Resources Business Partner-Associate Director (HRBP AD) serves as an integral business partner on the People Experience team. The HRBP AD partners closely with firm leaders to deliver people related programs and initiatives and provide strategic direction and...

  • Home Therapies Dialysis Registered Nurse

    17 hours ago

    Raleigh, United States Fresenius Medical Care Full time

    Job DescriptionDescriptionInspire and inform each patient. Allow others to achieve their most important objectives while you achieve yours. Improve their prospects-and the vitality of your career. Connect with your goals and change liveswith Fresenius Medical Care North America.Create strong, vital connections with your knowledge and kind reassurance....

  • Home Therapies Dialysis Registered Nurse

    13 hours ago

    Raleigh, United States Fresenius Medical Care Full time

    Job DescriptionDescriptionInspire and inform each patient. Allow others to achieve their most important objectives while you achieve yours. Improve their prospects-and the vitality of your career. Connect with your goals and change liveswith Fresenius Medical Care North America.Create strong, vital connections with your knowledge and kind reassurance....

  • CRNA - Certified Registered Nurse Anesthetist

    2 days ago

    Raleigh, NC, United States Fresenius Medical Care Full time

    PURPOSE AND SCOPE: A Certified Registered Nurse Anesthetist (CRNA) in an advanced practice registered nurse (APRN) who practices both autonomously and in collaboration with a variety of health providers on the interprofessional team to deliver high-quality, holistic, evidence-based anesthesia and pain care services. The CRNA cares for patients at all acuity...

  • Home Therapies Dialysis Registered Nurse

    2 days ago

    Raleigh, NC, United States Fresenius Medical Care Full time

    Description Inspire and inform each patient. Allow others to achieve their most important objectives while you achieve yours. Improve their prospects-and the vitality of your career. Connect with your goals and change liveswith Fresenius Medical Care North America. Create strong, vital connections with your knowledge and kind reassurance. Enhance lives and...