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regulatory affairs in Newark

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  1. DBA, Scientific Programmer at Chromocell Corporation

    JOB SUMMARY: The ideal candidate for this role will be well-organized and detail-oriented with strong abilities in problem solving as well as oral and written

  2. Director, Regulatory Lead, Development & Marketed Product Support at LEO Pharma

    Regulatory Affairs department. 5-7+ years of experience working within Regulatory Affairs. Expert Knowledge regulatory affairs within one or more therapeutic...

  3. Corporate Account Manager, Market Access, Midwest at LEO Pharma

    Minimum 3 years Pharmaceutical, biotech, or medical device sales experience required. LEO Pharma is an independent, research-based specialty pharmaceutical...

  4. Senior Regional Sales Manager at Fluidigm

    A Science Background. We make biotech tools that enable our customers and ourselves to seek truth in applied life sciences....

  5. Outreach Specialist at Willdan & Associates

    Outreach Specialist – San Diego, CA. The position will be based in our San Diego, California office, and will support the program by identifying,

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    1. REGULATORY SPECIALIST

      The Market Access Regulatory Specialist will be responsible in helping to define US regulatory submission strategies. He/She will be responsible for drafting and reviewing submission documents and interacting with other individuals within the Market Access Department as well as with regulatory bodies to assure timely and successful product clearances. Beyond the US, interactions could be with ...

    1. Corporate Relations Director at National Kidney Foundation

      Pharmaceutical, biotech and medical device/equipment manufactures. Maintain and grow existing relationships with pharmaceutical, biotech and device companies in...

    1. Director of Medical Science/Translational Research

      Director of Medical Science/Translational ResearchThe Director of Medical Science/Translational Research will join our evolving Medical Science/Translational Research team in Clinical Research to investigate indications (i.e. how to clinically use a molecule) and create clinical development for new molecules. The expected therapeutic areas will be immunology, dermatology, internal medicine or ...

    1. Senior Medical Writer, Regulatory Writing at INC Research

      Management, biostatistics, regulatory affairs, and medical affairs as necessary. Life sciences, clinical sciences, English/journalism, or equivalent related....

    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. Senior Medical Writer, Early Phase at INC Research

      Management, biostatistics, regulatory affairs, and medical affairs as necessary. Life sciences, clinical sciences, English/journalism, or equivalent related....

    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. R&D Program Management Office Manager (PMO) at C.R. Bard International

      Understands and follows company procedures and regulatory requirements. Bard Peripheral Vascular, located in Tempe, AZ – where a tradition of vascular...

    1. Clinical Data Analyst

      Responsibilities:Plans and coordinates Ongoing Data Review (ODRM)/ Risk Base Monitoring (RBM) deliverables for multiple projects/ studies, inputs into RBM plan and specification for identified outputsSet up and generate outputs using visual tools with clinical data for ODRM/RBM variables across multiple projects/studiesCommunicate findings from data and to create interactive visualizations ...

    1. R&D Program Management Office Manager (PMO) at C. R. Bard

      Understands and follows company procedures and regulatory requirements. Bard Peripheral Vascular, located in Tempe, AZ – where a tradition of vascular...

    1. Clinical Data Analyst

      Responsibilities:Plans and coordinates Ongoing Data Review (ODRM)/ Risk Base Monitoring (RBM) deliverables for multiple projects/ studies, inputs into RBM plan and specification for identified outputsSet up and generate outputs using visual tools with clinical data for ODRM/RBM variables across multiple projects/studiesCommunicate findings from data and to create interactive visualizations ...

    1. Used Inventory Clerk- STADIUM NISSAN at Ken Garff Auto Group

      A c omp r ehensive benefits p r ogram has been c r eated to fulfill a wide range of needs. Ken Garff recognizes the importance of a benefit p r ogram that p r...

    1. Drug Safety Physician

      Vivos Professional Services is currently seeking candidates for a Pharmacovigilance Leader opportunity in East Hanover, New Jersey. Incumbent performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator ...

    1. Director, Global Marketing, Multiple Myeloma at Celgene

      Partners with Global Medical Affairs lead on publication planning, IIT, KOL and Med Education strategies....

    1. Drug Safety Physician

      Vivos Professional Services is currently seeking candidates for a Pharmacovigilance Leader opportunity in East Hanover, New Jersey. Incumbent performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator ...

    1. Content Editor (Employee Communications & Initiatives) at Hired by Matrix, Inc.

      We recruit for a variety of job types including IT, Finance and Accounting, R & D, Engineering, Administrative and Light Industrial....

    1. Clinical Data Analyst

      Responsibilities:Plans and coordinates Ongoing Data Review (ODRM)/ Risk Base Monitoring (RBM) deliverables for multiple projects/ studies, inputs into RBM plan and specification for identified outputsSet up and generate outputs using visual tools with clinical data for ODRM/RBM variables across multiple projects/studiesCommunicate findings from data and to create interactive visualizations ...

    1. Project Director II - Hem / Oncology at INC Research

      Oversees the regulatory document collection and submission process. INC Research is a full-service contract research organization, providing the full range of...

    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. 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. Medical Director Medical Affairs Rheumatology

      Do you possess cutting edge experience in drug development and medical affairs, extraordinary leadership competencies, and the perspective needed to develop medical strategy around new Rheumatology medicines? Come to an industry leader where you will help drive the US Medical strategy for development and marketed products in the Rheumatology Therapeutic Area. The selected candidate will ...

    2. Drug Safety Physician

      Vivos Professional Services is currently seeking candidates for a Pharmacovigilance Leader opportunity in East Hanover, New Jersey. Incumbent performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator ...

    3. CMC Regulatory Manager

      Minimum Requirements:BS Degree in life sciences, or related scientific discipline8+ years of experience in a pharmaceutical setting with direct CMC related activities*Regulatory CMC experience responding to health authority questions and biologics experience.*Clinical submissions and post approvals submissionsExperience in CMC Regulatory affairs with biopharmaceutical products (monoclonal ...

    4. Food Technologist

      We are seeking a highly motivated R&D Technologist to join a growing highly successful business, Premio Foods’ Research and Development team. The Technologist will be responsible for performing product development work to meet project objectives, supporting innovation and brand maintenance initiatives. Must be able to perform multiple, simultaneous projects. Our mission is to improve the ...

    5. Drug Safety Physician

      Vivos Professional Services is currently seeking candidates for a Pharmacovigilance Leader opportunity in East Hanover, New Jersey. Incumbent performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator ...

    6. 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 ...

      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. Software Engineer at The Macaluso Group

        Build leading edge solutions in pharmacy, biotech, retail, and payment processing. The Macaluso Group....

      3. Senior Software Engineer at The Macaluso Group

        Bachelor degree, Computer Science. Build leading edge solutions in pharmacy, biotech, retail, and payment processing. The Macaluso Group....

      4. Telecommunications Specialist at Data Path, Inc.

        Tea mw o r k, integ r i ty, inno v ation, leade r ship, and. D ata P ath i s an equal oppo r tunity. E m ployer c o mm i t t e d to building a dive r se gl o...

      5. R & D Data Analyst at Axelon Services Corporation

        Basic understanding of the Food Safety Modernization Act, domestic and international regulatory requirements. Part of the Food and Beverage Quality Program (PQP...