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regulatory affairs in Newark

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  1. Principal Scientist, Analytical Services at Par Pharmaceutical an Endo International Company

    Interact with other departments, e.g. RA, Formulations, Regulatory Affairs, Production, Supply Chain, etc, to support timely new product development/submission...

  2. Associate Director, Analytical Services at Par Pharmaceutical an Endo International Company

    Work in collaboration with other departments, e.g. RA, Formulations, Regulatory Affairs, Production, Supply Chain, etc, to support timely new product...

  3. Senior Manager, Transfer Pricing at KPMG

    Prepare and analyze financial and economic data for tax and regulatory compliance purposes through the use of MS Word, Excel, Access, and various statistical...

  4. Director, Clinical Studies at PixarBio Corporation

    Coordinate with Regulatory Affairs to determine and meet FDA guidelines and submission requirements. Leading society’s mandate for non-opiate and non-addictive...

  5. Executive Director, Early Clinical Development, Inflammation and Immunology Job at Celgene

    Regulatory authorities, liaison with companies, manufacturers, external. Investigators and agencies, clinical research organizations, and internal customers,...

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    1. Regulatory Affairs Associate #5644AS

      Our client, a leading Orthopedic company located in Parsippany, NJ, is looking for add a Regulatory Affairs Associate for an 8 month contract position.Position will pay up to $32.31/hr. based on experience and education.Regulatory Affairs Associate Job Summary:Responsible for assisting the team with regulatory filings as necessary to market products.  This is an entry level position, ...

    1. Director, Global Trial Management Job at Celgene

      Nonclinical & pharmaceutical development, regulatory, commercial/marketing). In depth knowledge of ICH/GCP, inspection readiness and support, regulatory...

    1. Regulatory Affairs Specialist

      Regulatory Affairs Specialist.Direct the preparation and submission of regulatory agency applications, reports, or correspondence. Manage, review critically and submit ANDA/NDA/IND submissions and amendments to FDA with an overall objective to receive approval within the shortest timeframes possible. Develop product regulatory strategy for assigned projects & products for registration, ...

    1. Manager, Regulatory Operations Job at Celgene

      Working with Regulatory Affairs and contributing functional areas in establishing submission plans. Experience in Regulatory Operations....

    1. Regulatory Affairs Specialist

      Maintains technical files for in vitro diagnostic products in compliance with the European In Vitro Diagnostics Directive 98/79/EC (IVDD). Prepares and reviews regulatory documentation to support conformance to the IVDD. Must possess good technical writing skills and have a scientific background. Knowledge and experience with development and global registration of in vitro diagnostic products ...

    1. NJ-Head of Regulatory Affairs at ASM, Associates in Scientific Management

      The Head of Regulatory Affairs*. Develop regulatory strategies to ensure the shortest FDA review and approval times for regulatory applications....

    1. REGULATORY AFFAIRS ASSOC I

      Our client is a world leader and innovator in the Pharmaceutical industry. They offer continuous growth, learning, and development for their employees. Since 1980 APR Consulting, Inc. has provided professional recruiting and contingent workforce solutions to a diverse mix of clients, industries, and skill sets nationwide. Job Title: Regulatory Affairs Associate I. Job Details: The RA ...

    1. Associate Director, Quality Assurance, Biologics at Celgene

      Good Knowledge of CMC Regulatory Affairs for development. Track/Own ongoing regulatory updates to Health Authorities (e.g....

    1. Manager, Regulatory Affairs (CMC)

      Exciting Regulatory Affairs Manager opportunity with a pharmaceutical company in the Newark, NJ area! There is room for growth in this position!Key Points: Candidate must have small pharma/biotech industry experienceMust have experience with generic pharmaceutical products (preferably in sterile and/or injectable products)This position will have a heavy CMC focusMust be willing to travel ...

    1. Director, Regulatory Affairs Job at Celgene

      Develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC....

    1. Regulatory Affairs Associate

      A leading company in the biopharmaceutical industry is currently seeking a Regulatory Affairs Associate - CMC to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details: 1) Manage regulatory affairs activities for designated projects 2) Compile and prepare routine regulatory submissions to support existing US IND and BLA applications, ...

    1. Medical Director / Lead Medical Director Medical Affairs - Neuroscience at Novartis

      Medical Affairs and U.S. Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for...

    1. Regulatory Affairs Specialist

      A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Regulatory Affairs Specialist role. Our client, a leading pharmaceutical company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. 1) Contribute to the development and ...

    1. Executive Director, Lymphoma/CLL Lead Job at Celgene

      Development, Regulatory Affairs, Managed Care, Pharmacovigilance, etc. Lead Medical Affairs Tumor-specific sub-team:....

    1. Vice President of Regulatory Affairs

      A brilliant opportunity exists for an outstanding individual capable of fitting in to this very rewarding VP Regulatory Affairs - Generics role. Our client, a leading pharmaceutical company, is looking to hire someone who can bring additional value to the role. If you’re dedicated and energetic, and can ensure thorough attention to detail at all times, this could be the perfect role for you. ...

    1. Director, Development Quality Assurance (Operations) Job at Celgene

      Good working knowledge of CMC Regulatory affairs. Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live...

    1. Director of Regulatory Affairs

      A leading company in the pharmaceutical industry is currently seeking a Director of Regulatory Affairs to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details: 1) Develop the regulatory strategy, oversee all regulatory operational activities and function as the key point of contact for regulatory interactions 2) Ensure overall ...

    1. Senior Manager, Trial Safety Surveillance at Celgene

      Interact with epidemiology, medical affairs and medical information for marketed compounds. Interact with clinical, biostatistics, data management, clinical...

    1. Regulatory Affairs Associate

      A leading company in the biopharmaceutical industry is currently seeking a Regulatory Affairs Associate - CMC to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details: 1) Manage regulatory affairs activities for designated projects 2) Compile and prepare routine regulatory submissions to support existing US IND and BLA applications, ...

    1. VP, Clinical Development & CMO at Noven Pharmaceuticals, Inc.

      O Regulatory Affairs. This includes leadership and supervision of clinical pharmacology, clinical research and operations, medical affairs and regulatory...

    1. Regulatory Affairs Associate

      A leading company in the biopharmaceutical industry is currently seeking a Regulatory Affairs Associate - CMC to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details: 1) Manage regulatory affairs activities for designated projects 2) Compile and prepare routine regulatory submissions to support existing US IND and BLA applications, ...

    2. Global Regulatory Affairs Head

      A leading company in the life sciences industry is currently seeking a Global Regulatory Affairs Head to join their team. The role will be challenging but also highly rewarding, and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Details: 1) Provide regulatory expertise to global product development teams 2 ...

    3. Regulatory Affairs Specialist

      A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Regulatory Affairs Specialist role. Our client, a leading pharmaceutical company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. 1) Contribute to the development and ...

    4. Director of Regulatory Affairs

      A leading company in the pharmaceutical industry is currently seeking a Director of Regulatory Affairs to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details: 1) Develop the regulatory strategy, oversee all regulatory operational activities and function as the key point of contact for regulatory interactions 2) Ensure overall ...

    5. 99576 - Regulatory Affairs Specialist

       Min Requirements:Global Regulatory CMC:This contract position will help establish several Regulatory CMC database as intelligence tools to achieve operational excellence across projects. Assignments also include supporting regulatory compliance aspect of commercial products through collaboration with country affiliates and CROs. The ideal candidate should have 3-5 years Regulatory CMC ...

    6. Regulatory Affairs Specialist

      A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Regulatory Affairs Specialist role. Our client, a leading pharmaceutical company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. 1) Contribute to the development and ...

    7. Regulatory Affairs Associate

      A leading company in the biopharmaceutical industry is currently seeking a Regulatory Affairs Associate - CMC to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details: 1) Manage regulatory affairs activities for designated projects 2) Compile and prepare routine regulatory submissions to support existing US IND and BLA applications, ...

    8. Administrative Assistant, Regulatory Affairs and Governance

      Requisition ID: WD60567 Administrative Assistant, Regulatory Affairs and Governance– Provide administrative support to agreed Leaders, by using exceptional business knowledge, stakeholder management, administrative abilities and personal judgement to execute primary responsibilities.– Arranging travel produces detailed itineraries and trip files and prepares expense reports for agreed Leaders ...

    9. Regulatory Affairs Specialist

      A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Regulatory Affairs Specialist role. Our client, a leading pharmaceutical company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. 1) Contribute to the development and ...

    10. Director of Regulatory Affairs

      A leading company in the pharmaceutical industry is currently seeking a Director of Regulatory Affairs to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details: 1) Develop the regulatory strategy, oversee all regulatory operational activities and function as the key point of contact for regulatory interactions 2) Ensure overall ...

      1. Director, Marketing Lymphoma Job at Celgene

        Lead and manage Lymphoma brand planning for the US market to ensure alignment across multiple functions including medical affairs, market access, marketing...

      2. Executive Director, Disease Lead USMA - Multiple Myeloma at Celgene

        Interface effectively with all Medical Affairs at all levels (global, regional, affiliate) and other departments, including Commercial, Clinical Research and...

      3. Director, Field U.S. Health Economics and Outcomes Research (HEOR) at Celgene

        Medical Affairs, Legal & Regulatory, U.S. Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer,...

      4. Director, Global Marketing, Multiple Myeloma at Celgene

        Partners with Global Medical Affairs lead on publication planning, IIT, KOL and Med Education strategies. Celgene is a global biopharmaceutical company leading...

      5. Senior Manager, Public Relations at PixarBio Corporation

        Coordinates Legal, Medical and Regulatory internal review process for materials developed. Potential litigation, product discontinuation and supply issues and...