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regulatory affairs in San Francisco Bay Area

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  1. Regulatory Affairs Associate-Technical Writer

      Regulatory Affairs Associate-Santa Clara CA 50304 4 months+ 38-43 an hour w2 contract Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of ...

  2. Regional Family Readiness Coordinator

    Company: Serco Inc. (Serco) is the Americas division of Serco Group, pic, one of the world's leading and most admired service companies. Serco serves Federal, state and local governments, along with the Canadian government and commercial customers. We help our customers deliver vital services more efficiently, while increasing the satisfaction of their end customers. Headquartered in Reston, VA, Serco has approximately10, 000 employees with an annual revenue of $1.2 billion and is part of a $7 ...

  3. Technical Writing

      My name is Jessica, and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a/an Technical Writing   position for a prominent client of ours.  This position is located in Berkeley, CA. Details for the positions are as follows:   Job Description/Requirements Assist lead CMC Specialist with various activities including writing the Quality Overall Summary for regulatory submission May include light project management activities and collaborating with other ...

  4. Senior Clinical Trial Manager

    A highly reputable pharmaceutical corporation is currently looking for a Senior Clinical Trial Manager to work in South San Francisco, CA. SUMMARY: The Senior Clinical Research Manager is accountable for the day-to-day operational oversight of clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity is coordinated in ...

  5. Director/Sr. Director, Regulatory Affairs

    HRC 01-18Company is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rate and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. We are launching five Phase 2 clinical trials and with another preclinical trial in the pipeline. Where possible, our strategy is to acquire and retain global commercialization rights to our products.  Come join our team during this exciting time of growth and opportunities! ...

  6. Director/Sr. Director, Regulatory Affairs

    Company is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rate and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. We are launching five Phase 2 clinical trials and with another preclinical trial in the pipeline. Where possible, our strategy is to acquire and retain global commercialization rights to our products. Come join our team during this exciting time of growth and opportunities! We are ...

  7. Sr. Systems Programmer/ Analyst - UNIX / SAS / XML - Biotech

    Full time position Salary: D.O.E. The Senior Systems Programmer Analyst is responsible for providing oversight of the BioMetrics Department validated and non-validated systems in the areas of system operations, analytics & applications support. -A minimum of six years SAS programming and applications development experience in pharmaceutical and/or biotech company. -Must possess an understanding of computers at system level with proficiency in UNIX and scripting. -Thorough knowledge of functional ...

  8. Director of Regulatory

    Director of Regulatory-Near Santa Clara, CA-AMAZING RELO AVAILABLE!! The Director of Regulatory will develop strategies for worldwide regulatory approval and introduction of the current generation and future generations of this clients medical device to market. Responsibilities: This position is responsible for, but not limited to, the following: : Develop a sense of regulatory leadership in the division on how the company will have a top notch regulatory system for the division's development ...

  9. Office Administration & Facilities Manager

    Manages overall administrative activities for the Office Administration and Facilities Department. Leads a team consisting of a receptionist, facilities technician and 3 administrative assistants. Oversees general office administrative support for employees/managers inclusive of travel arrangement, hotel/apartment contract rate negotiation, departmental activities such as team building or meetings, company-wide events, contract management, and other general office affairs. Oversees and ...

  10. Regulatory Affairs Project Manager

    Primary Job Function As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert and resource within the department. The individual may share knowledge and expertise with others in support of team activities. The ...

  11. REG AFFAIRS PROJ MGR - (14000005T6) (RK) A

    REG AFFAIRS PROJ MGR - (14000005T6) (RK) A Pharmaceutical / Biotech  Legal - Regulatory / Compliance Law Full-time United States - California - Santa Clara Jobs ID - 1040501 The Compensation Benefits - Full Bonus Eligible - Yes Interview Travel Reimbursed - Yes Detailed Job Description Job Description REG AFFAIRS PROJ MGR(Job Number: 14000005T6) Primary Job Function  As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, ...

  12. Clinical Document Associate - 2811

      Our client has a permanent Clinical Document Specialist position available in Mountain View, CA. Purpose of Position To support ongoing essential document collection and handling from multiple, global clinical studies. Summary: The ideal candidate should be comfortable working within a dynamic, fast paced environment including communicating with different functional areas CSMs, contractors, and vendors, as requested. Would also be eager to take on new responsibilities and support the team in ...

  13. Vice President of Global Regulatory Affairs

    NW Recruiters is seeking a Vice President of Global Regulatory Affairs. This role will be responsible for assisting in analyzing public policy developments, drafting responses to public policy, legislative and regulatory initiatives.​ Analyze regulatory frameworks in jurisdictions where the firm is or is considering carrying on business, preparing presentations relating to public policy, developing and operationalizing the firm’s South American strategy.​   Responsibilities Deepen the firm’s ...

  14. Director, Quality Assurance and Regulatory Affairs

    We are a small, private, medical device start-up company launching our first product. We are looking for a hands-on Quality Assurance and Regulatory Affairs Director who will responsible for all aspects of the quality and regulatory activities at the company. This person will be responsible for developing strategies for worldwide approval to introduce new and/or modified products to market. As the Management Representative, the Director has overall responsibility for the development, implementation ...

  15. Regulatory Affairs Associate

    Harvest Technical is seeking an Associate, Regulatory Affairs  for our Biotech client in the Greater Bay Area. Description:        The Associate, Regulatory Affairs is responsible for the coordination, preparation and submission of a variety of regulatory submissions including INDs, CTAs, BLAs and NDAs to regulatory authorities. RESPONSIBILITIES Attend project team meetings across functional areas Prepare, submit, and maintain domestic and international regulatory filings, both ...

  16. Regulatory Affairs Specialist - 53393

    Salary: Commensurate with experience Length: 11 Months Premium Healthcare Staffing Solutions LLC. is recruiting for a Regulatory Affairs Specialist. The candidate ensures  compliance to the FDA Quality System Regulations, European Requirements, and other regulatory requirements.         Researches medical literature, regulatory documents and related information for inclusion into clinical articles and regulatory submissions and for evaluating manuscripts for accuracy, completeness, and adherence to ...

  17. Regulatory Affairs Associate

        Hello,   My name is Jacqueline and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Regulatory Affairs Associate for a prominent client of ours.  This position is located in Santa Clara, CA. Details for the positions are as follows:   Job Description: Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting ...