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  1. Director - Regulatory Affairs  – FDA OPDA OPDP

    Full Time Permanent Position for a large US Company. B-768 Director - Regulatory Affairs  – FDA OPDA OPDP Location: Job is in Cambridge, MA Domain:  Medical Experience: 7-10 Years   Experienced Director - Regulatory Affairs is required having responsibility to deliver Regulatory compliance training to assigned team in preparation for scientific conferences.  Job Responsibilities: Will be responsible for directing the regulatory aspects of review and approval of promotional materials and ...

  2. Director - Regulatory Affairs  – OPDA OPDP FDA

    Full Time Permanent Position for a large US Company. B-768 Director - Regulatory Affairs  – OPDA OPDP FDA  Location: Job is in Cambridge, MA Domain:  Medical Experience: 7-10 Years   Experienced Director - Regulatory Affairs is required having responsibility to serve as the primary contact leading and facilitating communications with the Office of Prescription Drug Promotion (OPDP) and direct the timely submission of all applicable approved promotional materials to the FDA on Form 2253.  Job ...

  3. Regulatory Affairs Specialist - Job#: 14-01409

     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 Job Title: Regulatory Affairs Specialist Job Location: Portsmouth, NH Job#: 14-01409 REQUIRED QUALIFICATIONS: Bachelor's Degree required + 7 years medical device experience and work experience in regulatory affairs (less exp. required with higher degree), must have in-depth knowledge of U.S. and international regulations and firm ...

  4. Job Title :  Regulatory Affairs Specialist-802

    3 Month Contract in Portsmouth MN Job Title :  Regulatory Affairs Specialist-802 Job Duties :  Ensure compliance to the FDA Quality System Regulations, European Requirements, and other regulatory requirements. Prepare required documentation (510(k)s, technical files, dossiers) for domestic and foreign submissions and registrations. Attend design review meetings regarding design controls. Interacts with other departments to assist in determining the Regulatory pathways required for products ...

  5. Regulatory Affairs Consultant

    Our client is a biopharma company who's mission is to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions.   Their Clinical Divide:  They have someone going out on maternity leave and need a senior regulatory person to cover.  In addition, as they gear up for an NDA submission, activities will increase that will require more Regulatory support into 2015.   Project Scope:  The RA consultant will be the  Regulatory lead on a start up ...

  6. Strategic Executive Director Regulatory Affairs

      Strategic Executive Director Regulatory Affairs   Position Summary A rapidly growing and expanding biotech in Cambridge, MA is looking for an Executive Director Regulatory Affairs who will be integral to the worldwide strategy by planning and implementing Regulatory actions.  The ideal candidate will be a hands on individual who can work with the Regulatory team to ensure the company is complying with guidelines and regulations.  ESSENTIAL FUNCTIONS: · Organize and preparation of regulatory ...

  7. Director, Product Marketing - Renal/Anemia Management

    KEY OBJECTIVES & RESPONSIBILITIES:   The Director will drive the marketing efforts (planning/positioning; promotion; market access; and product life-cycle management) in the U.S. nephrology healthcare market segment. Collaborate with appropriate stakeholders and executives to help set the strategic direction and works to develop, execute/implement, and communicate the overall product marketing plan and strategies.  Assist with the establishment of short and long term goals and objectives for ...

  8. Medical Director, Medical Affairs

    Medical Director, Medical Affairs Location: Cambridge, MA (local candidates or those within the NE preferred) Position Type: Full-Time/Regular Our Client is a growing Biotechnology Company exploring targeted therapies for cancer. The Company seeks a Medical Director who is highly motivated to make key contributions to Medical Affairs Research and Communications.  The successful candidate will actively lead and participate in a broad range of Medical Affairs activities including, but not limited to ...

  9. Sr. IT Program Manager, Regulatory Affairs

    Sr. IT Program Manager, Regulatory Affairs Permanent Position! Location: Lexington, MA Position Summary: Note: This position is not available for Visa sponsorship. Candidate must be legally authorized to work in the United States for any employer without the need for sponsorship Description: The Senior IT Program Manager, Regulatory Affairs will be responsible for supporting Regulatory Affairs business units.  She/he will perform program and project management as well as become a valued client ...

  10. 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 ...

  11. 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 ...

  12. Global Project Manager- 3983764

      Marlborough site is engaged in medical device design and development. Project teams at this site are interfacing with teams for projects: involving clinical trial validation studies, regulatory submissions, and launch activities as well as projects involving instrument design, development and transfer. An experienced individual with general project management expertise is needed at the Marlborough site to coordinate planning and activities involving all three sites. Duties: Leads in the ...