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regulatory affairs in Newark

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    1. Regulatory Affairs Associate - CMC

      Regulatory Affairs Associate – CMC: Near Edgewater, NJ area Position Overview Regulatory Affairs Specialist – CMC: Ensures regulatory compliance by determining submission requirements for development projects and review of CMC changes to current marketing applications. The Regulatory Affairs Associate Director – CMC is also responsible for providing information to cross-functional team ...

    2. Regulatory Affairs Associate - CMC

       Regulatory Affairs Associate – CMC: Near Edgewater, NJ area   Position Overview Regulatory Affairs Specialist – CMC:  Ensures regulatory compliance by determining submission requirements for development projects and review of CMC changes to current marketing applications.  The Regulatory Affairs Associate Director – CMC is also responsible for providing information to cross-functional ...

    3. Regulatory Affairs/Documentation Manager

      Hello,   My name is Domenic and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Regulatory Affairs/Clinical Documentation Manager for a prominent client of ours.  This position is located in East Hanover, NJ. Details for the position are as follows:   Job Description:   Duties: Experience desirable. The following activities may be performed ...

    4. Regulatory Affairs Manager

      Job Description: This role will be part of the Regulatory Organization supporting the business through the preparation of product submissions, license renewals, label & advertising reviews, product development team participation, and other regulatory affairs support activities. This position will interface with key business and cross-functional stakeholders to ensure that the commercial ...

    5. Regulatory Affairs

      Minimum Requirements:       We are looking for a Regulatory Associate to work for one of our clients in Princeton, NJ. 3 years Regulatory Affairs experience with prior experience supporting (Cosmetics, Medical Devices and OTC) dermatological products. Strong knowledge of FDA regulations and guidances. Proven quality assurance knowledge Demonstrated ...

    6. Regulatory Affairs

      Minimum Requirements:       We are looking for a Regulatory Associate to work for one of our clients in Princeton, NJ. 3 years Regulatory Affairs experience with prior experience supporting (Cosmetics, Medical Devices and OTC) dermatological products. Strong knowledge of FDA regulations and guidances. Proven quality assurance knowledge Demonstrated ...

    7. Executive Director | Regulatory Affairs

      One of the world’s largest biopharmaceuticals firms is looking for a Global Regulatory Affairs Executive Director with cross-therapeutic experience   Executive Director Level | Regulatory Affairs | Cross-Therapeutic Location: New Jersey Salary: $240,000 - $300,000 + bonus + excellent benefits + relocation One of the world’s largest biopharmaceutical and medical device companies is ...

    8. Director, US Medical Device Regulatory Affairs (429825)

      Overview: Regulatory support of new and marketed Medical device products and assigned combination drug products, including: •    Liaison with FDA, as necessary, including arranging and attending face-to-face meetings. •    Advise on regulatory strategy and tactics and follow through to implementation, submission, and clearance/approval •    Preparation of periodic reports to FDA (Annual ...

    9. Medical Writer - Regulatory and Medical Affairs (97976)

      Job Description: A Medical Writers (Regulatory and Medical Affairs) is needed for 12-month contract positions at major pharma company in Northeast. Minimum Requirements Education, Experience and Skills: PharmD, PhD, or MD with a minimum of 2 years experience in medical writing. Oncology experience is strongly preferred. Pharmaceutical industry experience or Medical Communications ...

    10. Regulatory Affairs Specialist

      POSITION DUTIES:• Provide Regulatory Support for Current Products and Development Projects Execute strategy and provide regulatory support and input. Deliver projects and other initiatives to progress current product portfolio by providing regulatory direction and support to stakeholders: o Collect and collate data required for registration submissions. o Prepare submission packages for the ...

    11. Regulatory Affairs Manager

      Job Description: This role will be part of the Regulatory Organization supporting the business through the preparation of product submissions, license renewals, label & advertising reviews, product development team participation, and other regulatory affairs support activities. This position will interface with key business and cross-functional stakeholders to ensure that the commercial ...