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  1. Clinical Data Analyst at ICON Clinical Research

    Work with Data Management, Clinical Operations, Central Laboratory, ITG, Biostatistics, Medical Writing, Regulatory Affairs and Quality Assurance to ensure all...

  2. Regulatory Affairs / RA Specialist at Sterling Hoffman Life Sciences

    Preference will be given to people who have recent experience in Regulatory Affairs. Process complaints and submit regulatory reports as required....

  3. Sterilization and Microbiology Auditor / Expert at Tuv America

    Perform evaluations of regulatory submissions including:. TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and...

  4. Medical Device Auditor at Tuv America

    TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has an immediate opening at our offices in the...

  5. Pressure Vessel Engineer / Auditor at Tuv America

    TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has an immediate for:....

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    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 ...

    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 team ...

    3. 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 ...

    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 ...

    5. 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 ...

    6. 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 ...

    7. 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 ...

    8. 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 ...

    9. 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 ...

    10. 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 ...

    11. 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, ...

    12. 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 ...

    13. 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 ...

    14. Sr. Director, Commercial Regulatory Affairs - Pharmaceutical Industry

      Senior Director. Commercial Regulatory Affairs - Pharmaceutical Industry Area of focus: Advertising, Promotion and Labeling Parsippany NJ 07054     Our client is responding to its dramatic growth in product portfolio by creating a new position tasked with the regulatory oversight and hands-on partnering with Marketing and Sales organizations to ensure all branding, advertising and ...

    15. Sr. Director Regulatory Affairs - Biotechnology/Pharmaceutical Industr

      Senior Director Regulatory Affairs - Biotechnology / Pharmaceutical Industry Focus: Marketed Products - Acute Care, Hospital Sector Parsippany, New Jersey   Help build the Regulatory Affairs infrastructure for a fast growing and evolving Bio Tech with a leading new Bio-Pharmaceutical pipeline.     Our client is evolving into a business with an expanding portfolio of drugs in ...

    16. 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 ...

    17. Sr. Regulatory Affairs Associate - Labeling

      Our client - a major Pharmaceutical Company in Central NJ - is looking for a Sr. Regulatory Affairs Associate - Labeling.The Labeling Associate will be responsible for the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes.They will also be responsible for the creation of labeling in both SPL and PLR format as ...

    18. Sr. Regulatory Affairs Associate

      Our client - a major Pharmaceutical Company in Central NJ - is looking for a Sr. Regulatory Affairs Associate.The Sr. Regulatory Affairs Associate with be responsible for preparing, reviewing, performing Gap Analysis, and submitting Drug Master Files (Type II, IV and V) according to US FDA requirements.This person will also serve as a regulatory representative on cross-functional teams.These ...

    19. 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 ...

    20. Sr. Regulatory Affairs Associate - Labeling

      Our client - a major Pharmaceutical Company in Central NJ - is looking for a Sr. Regulatory Affairs Associate - Labeling.The Labeling Associate will be responsible for the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes.They will also be responsible for the creation of labeling in both SPL and PLR format as ...

    21. Sr. Regulatory Affairs Associate

      Our client - a major Pharmaceutical Company in Central NJ - is looking for a Sr. Regulatory Affairs Associate.The Sr. Regulatory Affairs Associate with be responsible for preparing, reviewing, performing Gap Analysis, and submitting Drug Master Files (Type II, IV and V) according to US FDA requirements.This person will also serve as a regulatory representative on cross-functional teams.These ...

    22. 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 ...

    23. Sr. Regulatory Affairs Associate - Labeling

      Our client - a major Pharmaceutical Company in Central NJ - is looking for a Sr. Regulatory Affairs Associate - Labeling.The Labeling Associate will be responsible for the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes.They will also be responsible for the creation of labeling in both SPL and PLR format as ...

    24. Sr. Regulatory Affairs Associate

      Our client - a major Pharmaceutical Company in Central NJ - is looking for a Sr. Regulatory Affairs Associate.The Sr. Regulatory Affairs Associate with be responsible for preparing, reviewing, performing Gap Analysis, and submitting Drug Master Files (Type II, IV and V) according to US FDA requirements.This person will also serve as a regulatory representative on cross-functional teams.These ...

      1. Position Title: Technical Services Specialist at Teva Pharmaceuticals

        R&D, Production, Regulatory Affairs, Quality, Sales, etc. This position requires extensive analytical, quality, compliance, compendial, and regulatory knowledge...

      2. Quality Management System Auditor at Tuv America

        TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has an immediate opening for a Quality Management...

      3. Project Manager, Clinical and CMC Planning at Planet Pharma

        Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business...

      4. Program Coordinator at Rutgers University

        This position is responsible for coordinating and supporting the regulatory affairs activities encountered in clinical research trials conducted by the Clinical...

      5. Senior Manager Regulatory Affairs - North NJ at MakroCare

        Senior Manager Regulatory Affairs- Newark, NJ*. 7-10 years in pharmaceutical industry regulatory affairs. 7-10 Yrs within regulatory affairs in pharma company:....