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  1. Regulatory Affairs Manager

    A Regulatory Affairs Manager job in Cambridge, MA 02139 is available courtesy of Adecco Scientific. The selected applicant should have a strong clinical background, with experience in general submission management, lifecycle management, regulatory strategy and labeling. Regulatory experience in both the US and Canada is preferred. Regulatory Affairs Manager job responsibilities include:• Provides input into the development of regional RA strategies• Monitors local guidelines and vaccine specific ...

  2. Director - Regulatory Affairs  – OPDA FDA - Cambridge, MA

      Full Time Permanent Position for a large US Company. B-768 Director - Regulatory Affairs  – OPDA FDA - Cambridge, MA Location: Job is in Cambridge, MA Domain:  Medical Experience: 7-10 Years   Experienced Director - Regulatory Affairs is required having responsibility For directing the regulatory aspects of review and approval of promotional materials and marketing activities for applicable company products and/or acquisitions. Job Responsibilities: Will be responsible for directing ...

  3. Associate Director, Biologics CMC Dossier Development and Coordination

    The CMC Dossier Development and Coordination (CDDC) department within the R&D Scientific Core Platforms (SCP) organization has the broadly defined roles and responsibilities for the development, coordination and delivery of high-quality CMC dossiers in a timely manner for all small and large molecule based pharmaceutical and biopharmaceutical products from First in Human clinical studies to Market Authorization Applications. Examples of CMC dossier deliverables include but are not limited to: o IND ...

  4. ASSOC DIR BIOSURGERY REGULATORY AFFAIRS (RK) B

      ASSOC DIR BIOSURGERY REGULATORY AFFAIRS (RK) B Pharmaceutical / Biotech  Root of Jobs - Research & Development Full-time United States - Massachusetts - Cambridge Jobs ID - 916864 The Compensation Benefits - Full Relocation Assistance Available - Possible for the ideal candidate Bonus Eligible - Yes Interview Travel Reimbursed - Yes Detailed Job Description Job Title:  Associate Director, Regulatory Affairs   Department Description This position will be based in Cambridge, Mass as part of the ...

  5. Regulatory Affairs Specialist - Job#: 14-01140

      Our client in Portsmouth,NH is looking for a Regulatory Affairs Specialist. This is a long term consulting position. If interested, Please apply to this ad Position: Regulatory Affairs Specialist Location:- Portsmouth,NH Job#: 14-01140 JOB DESCRIPTION: The Regulatory Affairs Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. They provide subject matter expertise and are responsible for advising and guiding the ...

  6. Communications Manager – Regulatory Affairs Business Operations

    Title: Communications Manager – Regulatory Affairs Business Operations Job ID: 4958 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 12 Month Contract Pay Rate Range: Depends on Experience (W-2 all inclusive rate)     This role will be based in Cambridge, Massachusetts and will report to the Senior Director, Regulatory Affairs Business Operations.   Job Details: The person selected for this role must have outstanding writing and communication skills, with a proven ability ...

  7. Senior Clinical Project Manager

    Note: Candidates must possess Ph. 1 and 2 Full Service Oncology PM Experience ~~SUMMARY: The Clinical Operations Senior Project Manager (SPM) is responsible for overall management of all phases of clinical trials, from start-up through completion of activities, utilizing MedSource or sponsor Standard Operating Procedures (as applicable), FDA regulations, and ICH-GCP guidelines. In-depth knowledge and experience of the drug development process is required, including study initiation, clinical ...

  8. Manager, Regulatory Affairs Labeling

    HRC 02-19Top Tier Pharmaceutical company- looking to expandContract role (6 months, w-2 and then renewable up to 4 years)(Manager, Regulatory)Thank you  Coverage Contractor for Manager, Global Labeling   Position Summary:  •Develops/authors and leads the execution of global labeling as the primary labeling representative on project teams for assigned products throughout clinical development cycle gaining buy in from key stakeholders.  •Develops and applies a comprehensive understanding ...

  9. Manager, Regulatory Affairs Labeling

    Top Tier Pharmaceutical company- looking to expandContract role (6 months, w-2 and then renewable up to 4 years)(Manager, Regulatory)Thank you Coverage Contractor for Manager, Global Labeling Position Summary: •Develops/authors and leads the execution of global labeling as the primary labeling representative on project teams for assigned products throughout clinical development cycle gaining buy in from key stakeholders. •Develops and applies a comprehensive understanding of global ...

  10. Manager of Regulatory Affairs

    A leading company in the pharmaceutical industry is currently seeking a Manager of Regulatory Affairs to join their team. For the right candidate, this is a fantastic opportunity with great growth prospects. Details:<br><br>1) Ensure timely preparation of organized and scientifically valid submissions<br>2) Prepare various regulatory submissions for product approval or registration<br>3) Provide pro-active strategic regulatory advice and operational regulatory support to multidisciplinary project ...

  11. Project Managers with Bio-Pharm, Clinical Trial or Healthcare Exp

    Alliance BioPharm & Health Partners is seeking experienced Project Managers with background managing Pharmaceutical, Healthcare Implementation and Clinical Projects for Client Engagements.   Opportunities exist for Project Managers  in the following areas Atlanta, GA    Boston, MA   Rockville, MD   Chicago, IL ,  Philadelphia, PA   In this role, you will work with respected pharmaceutical, healthcare, clinical research companies where you will you will be responsible for the delivery of a wide ...