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  1. Director Regulatory Affairs at HARLAN Staffing Consultants

    Director Regulatory Affairs. Participate in industry trade groups and regulatory affairs organizations. Managing regulatory projects and product development....

  2. Sr. Regulatory Affairs Specialist at Sterling Hoffman Life Sciences

    Regulatory Affairs certification (preferred). Prepare and manage budget for the Regulatory Affairs department....

  3. Director, Ultrasound X-Ray at Sterling Hoffman Life Sciences

    Provide medical support to Regulatory Affairs, including preparation of regulatory documents for new and established products. Partial Job Description....

  4. SR REGULATORY AFFAIRS SPECIALIST II at West-Ward Pharmaceutical Corp.

    This position reports directly to the Senior Manager, Regulatory Affairs. File all FDA-required documentation for approval and maintenance of IND/ANDA/NDA...

  5. Associate Director Labeling at Sanofi

    Detailed knowledge of regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products;...

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    1. Regulatory Affairs Manager, FDA

      Regulatory Affairs Manager, FDA - Jersey City, NJ areaHandles day-to-day regulatory affairs matters and regulatory compliance relating to new food, treat and consumable product development and existing product lines coordinating such effort with relevant stakeholders such as Legal, QA, Marketing, Packaging and R&D departments.The Regulatory Affairs Specialist provides updates on existing and ...

    1. Investigator Clinical PK/PD at Novartis Institutes for BioMedical Research

      Translational Medicine, Toxicology, Formulation, Modeling & Simulation, Drug Regulatory Affairs, Clinical Development)....

    1. Regulatory Affairs Manager

      Regulatory Affairs Manager provides strategic and operational regulatory direction and documentation for projects / products covering product development, registration and approval / post approval activities. This individual will oversee the regulation process for products requiring regulatory approval, including filing necessary applications and handling all interactions with regulatory ...

    1. Staff International Regulatory Affairs Specialist at Becton Dickinson & Company

      Partnering with BD PAS Regulatory Affairs on New Product Development and Sustaining Engineering activities, as well as with the International Regulatory Affairs...

    1. Regulatory Affairs Manager

        Regulatory Affairs ManagerSouth PlainfieldSalary: $105K with 10% annual bonus based on individual and company performance All interviews are phone first and then a face to face Regulatory Affairs Manager provides strategic and operational regulatory direction and documentation for projects / products covering product development, registration and approval / post approval activities. This ...

    1. Sr. Medical Writer at Pearl Therapeutics Inc.

      Act as liaison between clinical trial teams, regulatory affairs and other functional groups. Regulatory medical writing experience preferred but not required....

    1. Manager Regulatory Affairs Crop Protection

      Our client is a leading global manufacturer of specialty chemicals used in crop protection. Due to their continued growth we are conducting a search for a Manager of Regulatory Affairs for their global Crop Care business. Crop Care develops appropriate regulatory programs, policies and procedures to maintain compliance with federal, state, local and Company requirements. The Regulatory ...

    1. Regulatory Affairs Specialist at Advanced Testing Laboratory, Inc

      Regulatory Affairs Specialist (Location:. Is seeking a Regulatory Affairs Specialist to join our dynamic team of highly-skilled professionals....

    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. Biostats Specialist at Medix

      As a statistician under the direction of Medical Affairs Statistics Disease Lead, actively provide statistical support to the Medical Affairs Department in the...

    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. Assoc Dir Labeling at Daiichi Sankyo, Inc.

      3+ years in global regulatory affairs. Review and interpret regulatory guidelines. Provide regulatory support (IND/NDA, TPP process, INN Preparation, Drug...

    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. Associate Regulatory Affairs Submission Specialist at G & W Labs

      Compile regulatory submissions to the FDA:. Communicate Regulatory requirements throughout the organization as appropriate....

    1. Regulatory Affairs Manager

      A brilliant opportunity exists for an outstanding individual capable of fitting in to this very rewarding Manager, Regulatory Affairs 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) ...

    1. North America Artwork Design Expert at Merck & Co.

      This role will also collaborate with, and provide design guidance, to Artwork Centers, Regulatory Affairs, Pack Sites and Print Suppliers within the Merck Sharp...

    1. Regulatory Affairs Associate

      Requisition ID: WD38879 RA Associate• The Associate, Regulatory Affairs works semi-autonomously and has responsibility for a portfolio of products, supporting a significant area of the business or function.• May interact with regulatory agency personnel in order to seek guidance, expedite approval of pending applications and to resolve regulatory matters.• Works with line-Manager to plan, ...

    1. Regulatory Affairs Technical Writer at Genpact Pharmalink

      CMC, Vaccines, Regulatory Affairs:. CMC, Regulatory Affairs, Vaccines or Biologics, Module 3:. Have you thought about a career in Regulatory Affairs Consulting?...

    1. Senior Manager, Regulatory Affairs

      Requisition ID: WD38878  NA Regulatory Affairs Sr. Manager Respiratory & Oral Care• The Senior Manager, Regulatory Affairs works autonomously with strategic direction from the functional leader. This role is a significant part of the overall function and is strategic and operational in nature.• Interacts with regulatory agency personnel in order to seek guidance, expedite approval of pending ...

    1. Regulatory Affairs Specialist at LifeCell Corporation

      Support product development teams representing Regulatory Affairs to provide input and answer questions related to regulatory requirements for both domestic and...

    1. Senior Director. Commercial Regulatory Affairs - Pharmaceutical

      Please send resume in word and a cover letter  Talent Orchard is exclusively contracted to manage recruiting activity for The Medicines Company, a fast growing, rapidly diversifying Bio-Pharmaceutical company headquartered in Parsippany NJ.The Medicines Company is responding to its dramatic growth in product portfolio by creating a new position tasked with the regulatory oversight and hands ...

    2. NA Regulatory Affairs Switch Director

      Requisition ID: WD38573  NA Regulatory Affairs Switch Director    Experience Required: 8 YearsThe new GSK CH organization has resulted in the creation of a key new role on the CH R&D Leadership Team accountable directly for Outside Innovation (external sourcing) and Cross-Category / New Category Innovation, including “switch”, as well as being accountable for best practice and consistency in ...

    3. Manager Regulatory Affairs Crop Protection

      Our client is a leading global manufacturer of specialty chemicals used in crop protection.  Due to their continued growth we are conducting a search for a Manager of Regulatory Affairs for their global Crop Care business. Crop Care develops appropriate regulatory programs, policies and procedures to maintain compliance with federal, state, local and Company requirements. The Regulatory ...

    4. 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 ...

    5. Regulatory Affairs Associate

      Job Description Role Description SummaryThe function of this position is to review and provide regulatory comments on technical documents. To attend meetings, provide regulatory guidance, receive and review documents,  prepare the regulatory submissions and submit to FDA.  Description of KEY responsibilities (describe the main results of the job to be achieved):Thorough review of technical ...

    6. 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 ...

    7. 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 ...

    8. Category Regulatory Affairs Senior Manager

      Requisition ID:WD35993 Category Regulatory Affairs Senior Manager, Smokers Health or Topical Skin The purpose of this role is to provide regulatory support to assigned products/projects or parts of projects to enable our products to be successfully introduced or maintained Globally. In this role the individual is likely to support other members of the functional team but may also work in ...

    9. Category Regulatory Affairs Director, Allergy & Decongestion

      Requisition ID: WD35992 Category Regulatory Affairs Director, Allergy & Decongestion Relocation:Yes The purpose of this role is to provide regulatory leadership, governance and expertise to one or two sub-categories or a significant portfolio of products such that our products are successfully introduced or maintained Globally. In this role the individual will build a network of ...

    10. 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 ...

    11. Senior Director of Regulatory Affairs - CMC

      Job Description The Senior Director of Regulatory Affairs for CMC Post Approval and Change Control is responsible for all aspects of CMC regulatory affairs during the post approval lifecycle of commercial projects as assigned by the Executive Director.The Director must have a firm understanding of US FDA CMC regulations and Guidance including applicable sections of the FD&C Act (Drugs), 21 ...

    12. Manager Regulatory Affairs CMC

      Job Description The primary responsibility is to submit CMC packages to HA and function as a liaison between Regulatory Affairs CMC and Quality Control, Quality Assurance, Manufacturing, Packaging, and Release sites to ensure on time submission of appropriate CMC documentation to Health Authorities (HA). This position will also ensure proper communication with all appropriate manufacturing ...

    13. Regulatory Affairs - Regulatory Strategic Liaison (RSL)

      Job Description The role of the Director, Regulatory Affairs is to provide expert leadership and managerial oversight for assigned team and projects to ensure delivery of high quality regulatory strategy and submissions. Further, this position will guide development programs to anticipate changes in the regulatory environment and approval requirements. Will serve as a credible, influential, ...

    14. 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 ...

      1. Manager\Sr Manager Global Regulatory Affairs Combination Products Medical Devices at Sanofi

        Manager/Sr Manager Global Regulatory Affairs Combination Products, Medical Devices-75010663-59054. Individual will need to identify, assess and communicate...

      2. Animal Originated Tissue Expert at Tuv America

        Perform evaluations of regulatory submissions including:. Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD),...

      3. Prin Medical Writer at Medtronic

        Collaborate with regulatory teams on all phases of regulatory submissions and approvals, including clinical document preparation and review, regulatory document...

      4. Clinical Study Design Specialist II at IDEXX Laboratories

        Familiarity with regulatory processes, clinical research processes and standards. Works with medical affairs and others to establish/refine study scope...

      5. Business Analysis and Reporting Manager at JPMorgan Chase

        Global Security and Military Affairs (GS&MA) safeguards the firm's employees and assets throughout the world....