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regulatory affairs in San Francisco Bay Area

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  1. Research Assistant at Predicine, Inc.

    Is a Silicon Valley-based biotech startup company focusing on precision diagnostics and medicine in cancer and other serious illnesses. Who We Are*....

  2. Clinical Data Standards Expert at Chiltern International

    Lead the collaboration between relevant functions (Clinical Operations, Clinical Science, Pharmacology, Data Management, Biostatistics, Regulatory Affairs,…) to...

  3. MSP- Program Consultant II at Pontoon

    Users to clarify job responsibilities, skills and other r equirements of specific requisitions. JOB....

  4. LabWare Validation/Training at LabAnswer

    Opportunities to work across a variety of laboratory environments (analytical testing, biotech, clinical trials, forensics, medical device, pharmaceutical,...

  5. STARLIMS SME/Developer and Configuration Specialist at LabAnswer

    The LIMS SME/Developer and Configuration Specialist will provide product knowledge for installing and configuring StarLIMS LIMS/ELN systems for Food and Drug...

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    1. Safety Scientist

      Saftey Scientists are needed for 12-month contract positions at major biotech company in Northern California.The Safety Scientist is responsible for carrying out pharmacovigilance activities on a product or group of products. This may include single case medical review, aggregate reporting, signal detection and evaluation, and other safety related activities e.g. associated with new drug ...

    1. Studio Artist at Giant Creative Strategy

      We’re an award-winning, full-service healthcare communications agency specializing in positioning, branding, and strategic and creative development for...

    1. Global RA Labeling Associate

      A Global Regulatory Affairs (GRA) Labeling Associate is needed for an 8-month contract position at major pharma company in Northeast.This Global Regulatory Affairs (GRA) Labeling Associate position will ensure active adherence to the local and global labeling processes using the appropriate tools and systems to ensure harmonization and compliance with company and GMP standards and ...

    1. Business Development Representative at Comparative Biosciences, Inc.

      Science (biology) background and/or scientific lab experience a plus. Is a unique pre-clinical contract research organization (CRO) offering boutique research...

    1. Clinical Project Publishing Mgr II

      A Clinical Project Publishing Manager II is needed for a contract position at major pharma company in Northeast.The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the regulatory community. The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global ...

    1. Sr. Supervisor, Production Engineering (GMP) at Impax

      Minimum 1+ years of Pharmaceutical, Biotech, Food, Cosmetic, Beverage or relevant work experience with increasing responsibilities preferred....

    1. Senior Scientist, Clinical Research

      About Aquinox:Aquinox is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Our primary focus is anti-inflammatory product candidates targeting SH2-containing inositol-5'-phosphatase 1, or SHIP1, which is a key regulator of an important cellular signaling pathway in immune cells, known as the PI3K ...

    1. Administrative Director at University of California San Francisco Medical Center

      Leads and directs practice staff with regard to patient safety, quality, and regulatory compliance issues. Demonstrates a high level of understanding of all...

    1. Senior Clinical Research Associate

      Summary: Biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. The onsite Sr. CRA will have a broad knowledge and understanding of literature in their therapeutic area and broad knowledge of FDA/EMA regulations of clinical issues. The Sr. CRA will be able to design, plan and implement the ...

    1. Director of Product Management, TiVo Cloud Services at TiVo

      At least 5 years experience as a product manage r in a technical environment with a minimum of for a large , scalable cloud-based consumer service or enterprise...

    1. Senior Regulatory Affairs Coordinator

      Regulatory Affairs CoordinatorWill be assisting RA product owners and managers with a variey of RA tasks including assessing product changes, helping with submissions, reviewing new standards and helping various RA teams based on need.Responsible for supporting the implementation of Regulatory Affairs and Quality Assurance systems and procedures relating to Domestic and/or International ...

    1. Deputy Director Labor Relations/Sr HR Business Partner at BAYER

      Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit...

    1. Director of Regulatory Affairs - Regenerative Medicine - San Jose, CA

      Seeking Regulatory Affairs leadership with a background in Regenerative Medicine to lead the development of strategies and objectives for the global regulatory affairs group in a growing pharmaceutical company with an exciting pipeline! Requires experience with the following: *** Developing regulatory policies, objectives, and strategies development and marketing of therapeutics, medical ...

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      No Freelance
      No Telecommute

    1. Territory Sales Representative at Ingenium

      5+ years Haz Waste, BioTech or Pharma Sales experience*. $50,000 - $85,000 DOE + commission*....

    1. Regulatory Technical Specialist

      Description:• Effectively implements the complaint handling process and processes complaints in a uniform and timely manner• Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals.• Drive the resolution of product issues in the field, ...

    1. Quality Intern-QRLP Life Sciences Intern at GE Healthcare

      Quality Assurance, Regulatory Affairs, Complaint Handling, Corrective & Preventative Action, QMS Compliance, Medical & Clinical Affairs, Global Audit and much...

    1. Regulatory Affairs Specialist (Complaint Handling)

      Hello, My name is Chrys and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Regulatory Affairs Specialist for a prominent client of ours. This position is located in Mountain View, CA Details for the position are as follows: Job Description:Effectively implements the complaint handling process and processes complaints in a uniform and timely ...

    1. Clinical Research Associate III (CRA) West Coast at INC Research

      You would also perform management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines....

    1. Senior Clinical Trials Manager

       Senior Clinical Trial Manager - South San Francisco, CA Position Summary:The Senior Clinical Trial Manager is a critical position within the clinical team. In close collaboration with the VP Clinical Operations & Regulatory Affairs, the Sr. CTM will be responsible for the operational management of company’s clinical trials.The Sr. CTM will partner with company’s Medical Monitor and other ...

    1. Medical Science Liaison/Sr. MSL Women's Cancer I/O - Northern CA/Reno, NV at AstraZeneca

      Adhere to internal standard processes and comply with regulatory and compliance requirements. The incumbent engages in scientific information exchanges with...

    1. Director, Clinical Operations (440087)

      OVERVIEW:The Director, Clinical Operations develops and implements strategic direction in the conduct of multiple clinical studies. Accountabilities include providing oversight to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements, and leading and directing ...

    2. Senior Clinical Project Manager (439611)

       OVERVIEW:This position will work with the clinical team to manage execution of clinical studies for Client's various products. The position will either focus on complex Phase 1 studies or global Phase 3 studies. Depending on project complexity and level of experience, this may include managing one or more clinical studies and/or managing a multi-national region for multiple global clinical ...

    3. Regulatory Affairs Director / Clinical Design Manager  Clinical Trials

      Too frequently, physicians exhaust all available treatment options for cancer patients. However, every cancer tumor contains unique genomic changes that can be targeted to attack the tumor. Our Client had developed sequencing which unlocks the genomic information physicians need to optimize treatment providing DNA-based cancer testing technology. The Regulatory Affairs professional will be ...

    4. 2 Regulatory Affairs Associate-PMA Annual reports-

      Regulatory Affairs Associate –SANTA CLARA CA59585 40-45.00 AN HOUR W2 CONTRACT 6 MONTHS+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 ...

      1. Scientist, Medicinal Chemist – Drug Discovery Program at Aduro Biotech

        Location: Berkeley, CA – USA Summary & Scope of Position: We are seeking a highly self-motivated, energetic and creative synthetic organic chemist with...

      2. R & D Specialist at EO Products

        You are: Passionate about cosmetics, the creation of a quality product, and being part of a dynamic team. You’ve got a scientific mind, and are just as

      3. In Mkt OTE Proj Coord, AL/FL at FL

        Lea rn in g an d development solution sets based on a broad spectrum of potential interventions. M easu re s pe r formance trends and develops new programs or...

      4. Biotech Marketing - Medical Education & KOL Strategy #5430 at The Alpine Group

        Science & Strategy A small Biotech company in the Bay area is growing rapidly and is adding a new Marketing Manager to the commercial team....

      5. Data Science Associate at Mckesson

        The Generics Analytics, Data Science & Operations team is seeking a Data Science Associate to support data science initiatives....