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regulatory affairs in San Francisco Bay Area

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  1. Project Timeline Manager, R&D at Intersect ENT

    His/her responsibilities not only encompass an understanding of process development, design control, clinical and regulatory affairs but also include leading...

  2. 2016 MBA Summer Internship - HIV Marketing at Gilead

    Team works closely with executive management, medical affairs, regulatory. Affairs, business conduct, marketing sciences and marketing operations to ensure....

  3. 2016 MBA Summer Internship - HIV Marketing at Gilead Sciences

    Team works closely with executive management, medical affairs, regulatory. Affairs, business conduct, marketing sciences and marketing operations to ensure....

  4. SPM/AD HIV DTP Marketing at Gilead

    Legal, Market Research, Training, Public Affairs, Government Affairs, Managed. Works collaboratively with Public Affairs to identify synergies....

  5. PM/SPM CF OLP Marketing at Gilead

    Must work cooperatively with commercial management, medical affairs, business conduct, regulatory, commercial operations, market research and others Ensure...

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    1. Caregiver: Novato Board-And-Care Needs Personal Care Staff, Part-Time

      We are a residential care facility for the elderly (RCFE) in Novato looking for someone to provide personal assistance, direct care and supervision of senior residents who are both ambulatory and non-ambulatory and who may have some degree of memory loss/dementia. We are licensed for 24/7 care of up to five residents. Immediate opening(s). AM, PM, On Call Shifts. Flexible work arrangements, 3-5 days/week. Phone inquiries should be directed to Les Wilson, Administrator at (415)446-8398. Qualifications: *Previous experience working with seniors preferred. CNA license a plus, but not ...

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    1. Biopharmaceutical Regulatory Affairs - SF Bay Area, all levels.

      With a variety of Biotech/Pharmaceutical clients through the San Francisco Bay Area (North Bay, SF, SSF, and East Bay) - there has been a recent influx of Regulatory Affairs opportunities of all levels! Starting with entry level assistant roles through Associate Director, we have a variety of competitive avenues which can help determine which opportunities may be a good match for your ...

    1. Senior Manager, Knowledge Management for Medical Affairs at Chiltern

      Knowledge of regulatory requirements and clinical data systems preferred. The position will collaborate with teams within medical affairs, IT and other groups...

    1. Biopharmaceutical Senior Program Product Manager

      Qualifications: Mid-senior level product management experience within biopharmaceutical industry; immunology exposure preferred.Experience in product launching and pre-launch marketing strategy development. Successful record connecting and collaborating with HCPs and KOLs.Experience working with PRBs, developing promotional materials, and training stakeholders and sales teams on product ...

    1. INTERNATIONAL STUDENT COORDINATOR at Central Michigan University

      Master’s degree in International Education, Educational Leadership, Student Affairs or related field....

    1. 99343 - Manager, Regulatory Management

      Minimum Requirements: Education:· Bachelors degree in Sciences or related field with 8 – 10 years of experience in regulatory, manufacturing and/or quality related field in the pharmaceutical or biotechnology industry.· The ideal candidate will have at least five years of regulatory submission experience, preferably with biological products. Skills and Experience:· Average of 5 or more years' ...

    1. Senior Clinical Quality Assurance Compliance Manager at Medivation, Inc.

      Clinical Development departments, Regulatory Affairs and Quality Assurance. Actively manage and/or support regulatory inspections and hosting partner audits....

    1. Clinical Project Manager

      SUMMARY:The Sr. Clinical Trials Manager is responsible for the day-to-day oversight or performance of operational tasks related to the conduct of 1-4 clinical trials commensurate with complexity, 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 ...

    1. Manager, Regulatory Affairs (Risk Management) at Jazz Pharmaceuticals

      Conduct research in support of commercial products and development project as it relates to regulatory requirements....

    1. Regulatory Program Director

      Position Title: Program Director, Regulatory Program Management / OncologyRegulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for the company’s global ...

    1. Cust Care Program Manager, Senior at Pacific Gas and Electric

      Internal stakeholders include the WE&T team, the Energy Efficiency Product and Program teams, Corporate Affairs, and Community Relations....

    1. Clinical Data Manager

      About the RoleThe Clinical Data Manager (DM) is responsible for the data management component of clinical trial projects including design of case report forms (CRFs) and execution of data processing in collaboration with the Medical Affairs team.  The DM may engage with study investigators, vendors and external stakeholders. In addition: Participates in the review and finalization of clinical ...

    1. Data Manager at Genpact Pharmalink

      Regulatory Affairs or Compliance and Quality Systems:. 1-3 years professional experience in the pharmaceutical industry preferably with Regulatory Affairs or...

    1. Regulatory Affairs Manager - 98330

      Minimum Requirements:  Education:·         Bachelors degree in Sciences or related field with 8 – 10 years of experience in regulatory, manufacturing and/or quality related field in the pharmaceutical or biotechnology industry.   ·         The ideal candidate will have at least five years of regulatory submission experience, preferably with biological products.    Skills and Experience:·      ...

    1. Medical Writer II at INC Research

      Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing...

    1. CMC Regulatory Affairs Manager (3751)

      Position Summary: This position is responsible for planning, coordinating and preparing regulatory submissions to various government health agencies such as the U.S. FDA and foreign counterparts, with an emphasis on CMC/quality submissions. Responsibilities: Plan, coordinate, and prepare regulatory documents such as original INDS, NDAs, and ANDs, amendments and supplements as well as ...

    1. Legislative Affairs Specialist II at American Federation of State, County and Municipal Employees

      This position serves as a primary lobbyist in the Federal Government Affairs Department. Responds to affiliate and members’ inquiries on a wide variety of...

    1. CMC Regulatory Affairs Associate III (3581)

      Position Summary: Independently prepares, reviews and submits high quality, regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include ANDAs, amendments, supplements, annual reports. Represent Regulatory Affairs in project teams and provide regulatory guidance to R&D and Operation teams as ...

    1. Regulatory Affairs Specialist II - Franklin TN at Wright Medical Technology, Inc.

      Implementation and management of electronic Regulatory submission processes including conversion of dossiers into the appropriate electronic format using...

    1. Engineer IV, Validation (Equipment, Utilities & Packaging) (4293)

      POSITION SUMMARY: Manages activities related to products and their processes. Working knowledge of Packaging equipment, solid oral dose manufacturing equipment and supporting systems (ie: USP Water System). Writes protocols for process and service related tasks and records test results. Prepares validation protocols. Performs technical and specialized engineering duties. Assists in ...

    1. Grievance System Manager at Partnership HealthPlan of CA

      Provides regulatory guidance to the Associate Director of Regulatory Affairs on issues regarding grievances....

    1. Regulatory Manager

      Job Description:A Manager, Regulatory Management is needed for a 12-month contract position at major biotech company in Northern California.In this role, the candidate will have responsibility for post-approval submissions for marketed biologics products in the product portfolio. Additionally, the candidate will support the regulatory teams in change management activities, maintenance, ...

    2. Study Start Up Specialist

      Job Description:Study Start-up Specialist is needed for a 7-month contract position at major biotech company in Northern California.Position Purpose:The Study Start-up (SSU) Specialist functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for ...

    3. Recruiter IV

      Job Description:Provide full-cycle recruiting and staffing services to management.Develop and implement sourcing and recruiting strategies to attract qualified external candidates to meet established business goals, objectives, and approved requisitions.Oversee the pre-employment process (background check, references, etc.).Ensure accurate and timely data is recorded in requisition and ...

    4. Project Manager (Contract or FTE) 1421

      Description:This candidate will be expected to operate independently under the broad guidance of the associate director of project management.Responsible for assisting the Clinical Trial Manager and clinical development functions in tracking, documenting, and ensuring quality and timely delivery of all clinical trial deliverables.Accountable for the implementation and maintenance of cross ...

    5. Contract Senior Recruiter

      The Company (Raptor Pharmaceuticals):Raptor Pharmaceutical Corp. (NASDAQ: RPTP), located in Novato, California (beautiful Marin County) is a commercialized global biopharmaceutical company focused on developing and commercializing life-altering therapeutics that treat rare, debilitating and often fatal diseases. Raptor’s first product, PROCYSBI® (cysteamine bitartrate) delayed-release ...

    6. Senior Administrative Assistant, Clinical Development & Regulatory1423

      Support executive director, regulatory affairs, VP clinical development and clinical operations. Provide complete administrative support for the team including but not limited to calendaring, complex travel arrangements (international and domestic), and coordination of meetings, facilitating timely responses to action items and other projects as assigned. Expected to partner with other ...

    7. Study Start-up Specialist , feasibility  99217

      Study Start-up Specialist  99217  Job Description:Three openings for Study Start-up Specialists that are needed to work for a major reputable biotech company in Northern California.Department: Clinical Site Management Minimum REQUIREMENTS: Education: University Degree (4yr degree) or Equivalent preferably in a medical or science-related fieldExperience: Prior work experience demonstrating ...

    8. Associate Project Manager Human Factors

      FRESENIUS CORE VALUES: Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values supporting our promise to improve the quality of life of every ...

    9. Associate Director/Director, Regulatory Affairs, Labeling, Adv 1405

      Provide regulatory expertise and guidance to internal stakeholders for successful development and implementation of regulatory labeling strategy and documentation for products in development.Provide strategic input into the development and approval of Core Data Sheets (CDS), US Package Insert (PI), Summary of Product Characteristics (SmPCs) and labels for global regions.Formulates regulatory ...

    10. Senior Compliance Program Manager | RoHS, REACH, and WEEE

      RoHS, REACH, and WEEE Subject Matter Expert needed for rapidly expanding Top-Tier Biotech Firm to interface with Senior Leadership·         Senior Compliance Program Manager | Product Environmental Compliance·         RoHS, REACH, WEEE Subject Matter Expert·         San Jose | California·         $120,000 - $160,000 + bonus + excellent benefits A rapidly expanding top-tier biotech med-device ...

      1. SPM/AD HIV DTP Marketing at Gilead Sciences

        Legal, Market Research, Training, Public Affairs, Government Affairs, Managed. Works collaboratively with Public Affairs to identify synergies....

      2. PM/SPM CF OLP Marketing at Gilead Sciences

        Must work cooperatively with commercial management, medical affairs, business conduct, regulatory, commercial operations, market research and others Ensure...

      3. Regulatory Affairs Analyst at Altegria

        Regulatory Affairs Analyst*. 3-6 years regulatory experience preferred. Develop and maintain positive relationships with regulatory agencies through oral and...

      4. Technical Service Manager at Kemin Industries, Inc.

        Ability to work in cross-functional teams to achieve customer and product objectives, including R&D, Regulatory Affairs and Operations....

      5. Program Manager (Regulatory Affairs) at PAREXEL International

        Acts independently in a client-facing role Provides a full range of consulting services and works within their personal area of expertise Takes responsibility...