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regulatory affairs in Raleigh

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  1. Paralegal Required – Long Term at Hire Counsel

    Must be able to collaborate and work with other departments such as Sales and Marketing, Clinical, Medical Affairs, Finance, Risk Management, IT, Regulatory,...

  2. Prin Medical Writer at Medtronic

    Collaborate with regulatory teams on all phases of regulatory submissions and approvals, including clinical document preparation and review, regulatory document...

  3. Entry to Mid-level Regulatory Scientist/Technical Writer at Critical Path Services, LLC

    Our regulatory affairs group is seeking a full-time entry to mid-level regulatory scientist or technical writer who has a degree in biology, chemistry,...

  4. Epidemiologist at Quintiles Transnational

    Represent Scientific Affairs at Bid Defenses and conferences. Design methodologically sound studies to meet project objectives and regulatory requirements....

  5. Regulatory Specialist at Agrinos, Inc.

    At least 3 years of experience in Regulatory Sciences or Regulatory Affairs. Lead regulatory project work such as regulatory competitive assessments and...

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    1. Medical Director, Clinical and Medical Affairs

      Opportunity: The Medical Director in Clinical and Medical Affairs (CMA) is a subject matter and technical expert in the procedures and educational programs offered by Teleflex. In this role, s/he will have an opportunity to work as part of a global, cross-functional team to make a meaningful difference in patient care through the incorporation of safe and effective product and procedural ...

    1. Scientist at Pearl Therapeutics Inc.

      Collaborate internally with Pearl analytical sciences, MDI manufacturing, formulation sciences, quality assurance, and regulatory affairs to effectively deliver...

    1. Staff Regulatory Affairs Specialist

       Staff Regulatory Affairs Specialist-REG000CK  (RK)Job DescriptionDescriptionStaff Regulatory Affairs Specialist will be responsible for developing regulatory strategies for moderately to highly complex submissions to US FDA and/or international regulatory agencies; providing risk assessments of strategies and regulatory options to business teams and to product development/support teams; ...

    1. Study Start Up Associate at Novella Clinical

      Notifies Regulatory Affairs department when initial essential documents are available for review. Works with Regulatory Department to....

    1. Quality Assurance Manager/ Regulatory Affairs

      Job Description Manager of Quality Assurance/ Regulatory AffairsSUMMARY OF POSITION:Directs all quality assurance and regulatory functions related documentation, finished product release, regulatory compliance, labeling, Annual Product Quality Reviews (APQRs), change control and oversight of the In-Process Quality Engineers (IPQEs) at the Raleigh site.ESSENTIAL FUNCTIONS:1. Oversee the proper ...

    1. Regulatory Compliance Specialist - Contract Position at Worldwide Clinical Trials

       Interfaces with the Regulatory Affairs Lead, Site Contracts Lead and Clinical Study Start-up Lead/Project Manager to ensure appropriate prioritization of...

    1. Medical Affairs Doctor - Skin & Joint Inflammation - Raleigh, NC

      Champion the creation of launch strategies for new products and oversee the development of product lifecycle management plans, marketing strategies and post-marketing Phase IV investigator sponsored study support. Functions: *** Medical and scientific expert, own all major educational activities surrounding the new product including demonstration of patient and economic benefits of new ...

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      No Contract
      No Internship
      No Freelance
      No Telecommute

    1. Vice Chancellor at North Carolina State University

      Representing NC State in UNC System, city, county, state, or federal governmental meetings dealing with financial and administrative affairs;...

    1. Regulatory Affairs Specialist

      Regulatory Affairs Specialist, Raleigh-Durham, NC (Direct Hire!) Kelly Services is currently seeking a Regulatory Affairs Specialist for one of our top clients in the Raleigh-Durham, NC. As a Regulatory Affairs Specialist you will provide administrative and technical support to the regulatory affairs, CMC, QA, and pre-clinical functions.Additional Job Responsibilities: Prepare document ...

    1. Sterilization and Microbiology Auditor / Expert at Tuv America

      Perform evaluations of regulatory submissions including:. TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and...

    1. Regulatory Affairs Senior Manager

      US Agent for the Company- Maintenance of Company Drug Establishment Registrations (DER) covering all sites- Drug Listing, Create NDC numbers- Provide information on GDUFA requirements and GDUFA feesMajor driver, develop and maintain the overall Company's US Regulatory strategy- Assist in the development and communication of and facilitate proper implementation ofregulatory strategies on ...

    1. Field Medical Educator at The Medical Affairs Company

      Identifies, collects, and communicates clinical insights and intelligence to address medical information, in addition to insights on trends and changes,...

    1. Director of CMC Regulatory Affairs

      Director, CMC Regulatory Affairs / Raleigh, NC Kelly Services is currently seeking a Director, CMC Regulatory Affairs (Direct Hire!) for one of our top clients in Raleigh, NC. As a Director, CMC Regulatory Affairs, you will be responsible for providing specialized knowledge and expertise relative to the development, registration and maintenance of the company's new drug and investigation ...

    1. Field Medical Educator (Immuno Oncology) - Southeast at The Medical Affairs Company

      Identifies, collects, and communicates clinical insights and intelligence to address medical information, in addition to insights on trends and changes,...

    1. Study Start Up Associate ( Contract) - 1510903

      Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents  (ED) and Investigator Site Files (ISF) throughout the clinical study.  Work with both internal and external teams to assure good communication, regarding documentation processing.  Assure documents maintained in ISSC are in compliance with International Congress on ...

    1. Regulatory Compliance Specialist at Sterling Hoffman Life Sciences

      Prepare annual regulatory affairs budget. Preference will be given to people having recent experience in regulatory affairs management....

    1. Regulatory Affairs Specialist

      Opportunity: The Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. Division Information: Teleflex partners ...

    1. Position Title: Medical Science Liaison - NeuroPsyc/Pain-CT at Teva Pharmaceuticals

      Director of US Field Medical Affairs within US Medical Affairs. Must have complete understanding of Teva products as well as medical, marketing, legal, and...

    1. Director of Marketing, Latin America

      Opportunity: The Director of Marketing for Latin American leads all efforts relative to marketing strategies for Vascular, Anesthesia, Surgical, Respiratory, Interventional Access, Urology, LMA, Vidacare and Urology in region. In this regard, this position oversees through delivery of strategic and tactical plans that are achieved through direct sales and distributors. This role provides ...

    1. Enlist Field Specialist - Mid South at The Dow Chemical Company

      Work with the Food Chain Leader and State Affairs Leader on outreach within the food chain, commodity groups, state department of ag, etc....

      1. Sr. Principal Scientist - Microbiology (Manufacturing Experience Required) at firstPRO Inc.

        Operations, Manufacturing/Materials Management, Supply Chain, Corporate and Plant Quality, Manufacturing, Regulatory Affairs, Marketing, Finance, Executive...

      2. Director Clinical Evidence & Healthcare Economics at Smiths Medical

        Establishes a close and productive working relationship with other departments within SM particularly Marketing and Clinical Affairs....

      3. VP Medical Affairs North America at Fairway Consulting Group

        Additional experience in related areas such as clinical development, regulatory affairs or pharmacovigilance could be a plus....

      4. Regulatory Affairs Specialist at Sterling Hoffman Life Sciences

        Minimum 3+ years of regulatory affairs experience. Monitor and decipher the regulatory environment. Work with and lead multi-departmental teams to implement...

      5. Staff Regulatory Affairs Specialist at Becton Dickinson & Company

        Description Staff Regulatory Affairs Specialist will be responsible for developing regulatory strategies for moderately to highly complex submissions to US FDA...