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regulatory affairs in Boston

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  1. Senior Compliance Engineer at Waters Corporation

    Support Regulatory Affairs with international IVD product submissions. Demonstrated competency of regulatory requirements including IVD medical device...

  2. Regulatory Affairs Labeling Consultant at BioforceSolutions.com

    The Regulatory Affairs, Labeling Consultant will be part of team that oversees all global regulatory labeling requirements are fulfilled for all new products....

  3. Biotechnology & Science Recruiter (Sales) – LEARN TO BE A RECRUITER! at HireMinds

    Biotechnology/Science Recruiter | Search Consultant Are you someone who craves a position that will pay you for your talents, rather than your tenure? Are

  4. Director, Clinical Studies at PixarBio Corporation

    Coordinate with Regulatory Affairs to determine and meet FDA guidelines and submission requirements. Leading society’s mandate for non-opiate and non-addictive...

  5. Senior Manager, Public Relations at PixarBio Corporation

    Coordinates Legal, Medical and Regulatory internal review process for materials developed. Potential litigation, product discontinuation and supply issues and...

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    1. Operations Manager

      Position Title: Operations Manager Reports To: General Manager Location: BOS Direct Reports: up to 40 Operation Size: 40 employees, ~13 departures daily Salary: 40-45K Annual Depending on experience Position Purpose: Lead and direct all day-to-day operational activities at the Boston, MA station. Responsibilities include but are not limited to aircraft service for all Spirit Airlines flights at the BOS International Airport. Safety, security, training and compliance are the cornerstones of this operation and are critical requirements to achieving operational excellence. It is absolutely ...

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    1. Regulatory Affairs Manager

       Hello, My name is Carlane and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Regulatory Affairs Manager position  for a prominent client of ours.  This position is located in Raynham, MA. Details for he position are as follows: Job Description:Administer the day-to-day Regulatory Affairs operations by directly or indirectly managing teams of ...

    1. Sr Strategic Sourcing Analyst Multifunction Devices (Manufacturing) at Medtronic

      Works directly with corporate functions (Legal, Audit, Quality/Regulatory Affairs, Tax) under the direction of the Sr....

    1. Medical Affairs Lead - Oncology Therapeutics - Boston, MA

      Seeking Medical Affairs leader to join a rapidly growing company and manage multiple oncology drug programs that could change the industry. *** Take charge of 'big picture' activities involved in a new drug launch for a potential blockbuster therapeutic. *** Put together a new medical affairs team to aid in building an entirely new brand. *** Establish strategies to further brand ...

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    1. Associate Medical Director, US Medical Affairs, Rare Diseases at Genzyme

      Medical affairs team. Ensure full compliance with all corporate and industry policies and legal and regulatory requirements, for all medical affairs activities....

    1. Medical Director - Oncology Drug Clinical Development - Medford, MA

      Seeking Medical Doctor with pharmaceutical or biotech industry experience progressing drugs from early Phase I through Phase III resulting in successful NDA submission. *** Lead the Clinical Development team during Phase I-III studies leading creation of clinical study development plans. *** Oversee Adverse Event and Serious Adverse Event reporting to safety monitoring and regulatory ...

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      No Telecommute

    1. Director, Market Development, Dupilumab Marketing Atopic Dermatitis - US at Sanofi

      Director, Professional Marketing and Market Development Lead, and have direct interface with national thought leaders, professional associations, Global...

    1. Data and Analytics Lead (Late Phase)

      Data and Analytics Lead (DAL) supporting World Wide Medical (resource for this req will solely support Phase IV/post marketing studies and therefore the candidates will need to have worked on these studies/phase) The World Wide Medical Biostatistics department is a distinct biostatistics group within the World Wide Medical organization that deals primarily with late phase clinical development ...

    1. Regional Clinical Research Associate at iCAD, Inc

      Review and collect regulatory documents and device accountability records. Accountable for data integrity, patient safety and regulatory compliance for assigned...

    1. Senior Director - Medical Affairs - New Oncology Drugs - Boston, MA

      Join a global company with several high-profile drugs in a diverse, strong pipeline including novel therapeutics treating blood cancers. *** Establish and maintain relationships with partners around the globe. *** Develop and manage medical affairs strategies focused on moving products from late-stage clinical trials to launch. *** Meet with key stakeholders including payors, patient ...

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      No Internship
      No Freelance
      No Telecommute

    1. Head of US Field, Health Economics and Outcomes Research at Sunovion

      Collaborate with and support internal functional areas including brand clinical development and medical affairs, health economics/outcomes research, managed...

    1. Sr. Regulatory Affairs (3983)

      Summary:The primary responsibility of this role is to oversee national/regional/global clinical projects/studies performed by Quintiles and other CROs under client's sponsorship including schedule and budget for clinical trial execution and ensuring clinical trials are conducted in accordance with client clinical procedures, ICH GCP Guidelines, the Declaration of Helsinki and national ...

    1. Director Nutrition Affairs at Dairy Management Inc.

      Director Nutrition Affairs. Collaborate with Nutrition Affairs team on joint work that advances achievement of goals....

    1. Project Manager (4033)

      Regulatory Project Management • Provide effective Project Management to Global Regulatory Teams (GRTs) that drive development and implementation of integrated regulatory strategies for investigational and marketed products. • Provide leadership and direction to ensure timely and quality end-to-end development and execution of project plans for client submission activity resulting in approvals ...

    1. Senior Safety Data Analyst at Sunovion

      Regulatory Affairs) in the compilation of Annual Reports. Compliance Achieve and maintain Compliance with all applicable regulatory, legal and operational rules...

    1. Academic Project Coordinator

      The main areas of responsibility for this position are: (a) managing large-scale, comprehensive Academic Affairs projects; (b) directing and analyzing data for institutional planning and assessment; and (c) coordinating meetings, activities, and operations of the Academic Affairs division. A particularly strong focus of this position will be on self-guided leadership and management of ...

    1. Senior Medical Director, Hematology/ Oncology, US Medical Affairs at Infinity Pharmaceuticals

      Represents Medical Affairs at the relevant Medical Affairs Committees within the AbbVie alliance. For our lead drug candidate, Duvelisib, the responsibility for...

    1. NECB Academic Project Coordinator

      The main areas of responsibility for this position are: (a) managing large-scale, comprehensive Academic Affairs projects; (b) directing and analyzing data for institutional planning and assessment; and (c) coordinating meetings, activities, and operations of the Academic Affairs division. A particularly strong focus of this position will be on self-guided leadership and management of ...

    1. Regulatory Affairs Coordinator - MGH Cancer Center Protocol Office at Massachusetts General Hospital(MGH)

      Collection, completion, and submission of regulatory documents to various regulatory entities. The Regulatory Affairs Coordinator (RAC) is responsible for the...

    1. 99819 - Regulatory Senior Manager

      Minimum REQUIREMENTS: Bachelor’s degree and 10+ years of experience in Regulatory Affairs or relevant industry experience, orMaster's, PharmD, PhD level are appropriate with relevant Regulatory Affairs industry experienceWorking knowledge of FDA and ICH requirements for standard regulatory documents and their maintenance.Excellent written and verbal communication skills, with ability to ...

    1. Government Affairs Attorney – Life Insurance at Homesite Insurance

      Acting as the primary contact for state Departments of Insurance and other regulatory agencies to address and resolve all regulatory issues associated with life...

    1. 99819 - Regulatory Senior Manager

      Minimum REQUIREMENTS: Bachelor’s degree and 10+ years of experience in Regulatory Affairs or relevant industry experience, orMaster's, PharmD, PhD level are appropriate with relevant Regulatory Affairs industry experienceWorking knowledge of FDA and ICH requirements for standard regulatory documents and their maintenance.Excellent written and verbal communication skills, with ability to ...

    2. Executive Director - Drug Resistant Infectious Disease Therapies

      Seeking Clinical Development leadership experience with specific expertise in drug trials for drug resistant infectious diseases. Shall: *** Develop, design, manage, and revise strategies for multiple clinical programs in pre Phase I through Phase III. *** Act as the medical expert for all key decisions regarding trials, patient safety, regulatory submissions, and FDA meetings. ...

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      No Contract
      No Internship
      No Freelance
      No Telecommute

    3. Jr. Project Manager - ICH Compliance

      Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis. Title: Project Coordinator, ICH ComplianceJob ID: 7909Industry: Biotech/PharmaceuticalLocation: Cambridge, MADuration: 6 Month ContractHours per Week: 15 hoursPay Rate Range: ...

    4. Clinical Operations Project Manager – Part-Time, ICH Compliance

       Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis.   Title: Project Manager – Part-Time, ICH Compliance Complexity: Intermediate Job ID: 7909 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 6 Month Contract Hours ...

    5. Medical Affairs Director - Boston

      1199 – Medical Affairs Director – Boston area Our client is a medical devices company with a patented and unique high tech FDA approved range of products sold to hospitals. The purpose for this Search For the US subsidiary located in the Boston area, the company is looking for a Medical Affairs manager. The position will report to the Medical Director of the company, based in Europe. The ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    6. Project Manager (4033)

      Regulatory Project Management • Provide effective Project Management to Global Regulatory Teams (GRTs) that drive development and implementation of integrated regulatory strategies for investigational and marketed products. • Provide leadership and direction to ensure timely and quality end-to-end development and execution of project plans for client submission activity resulting in approvals ...

    7. Sr. Regulatory Affairs (3983)

      Summary:The primary responsibility of this role is to oversee national/regional/global clinical projects/studies performed by Quintiles and other CROs under client's sponsorship including schedule and budget for clinical trial execution and ensuring clinical trials are conducted in accordance with client clinical procedures, ICH GCP Guidelines, the Declaration of Helsinki and national ...

    8. AD, CMC Project Manager

      AD, CMC Project ManagerJob SummaryIncumbent provides project management leadership and support to cross functional teams and respective expertise areas responsible for the completion of tasks required for the clinical and commercial development of new products (Phase 2 to Phase 3). This role is responsible for managing deliverables required to fulfill CMC requirements and timelines for all ...

    9. Reporter, Boston Courts

      Law360 is seeking a reporter to cover developments in the U.S. District Court, the Suffolk County Superior Court, the Massachusetts Supreme Judicial Court and the U.S. Court of Appeals for the First Circuit in Boston for our online daily business newswire. The Boston Courts Reporter will be responsible for keeping track of events in these courts, communicating with editors about which events ...

    10. Regulatory Affairs Specialist

      SUMMARY OF POSITION: Support and guide new product development programs from regulatory perspective; Ensure compliance to global regulations throughout total product life cycle; Develop and submit dossiers to various governing agencies in supporting global business growth; lead and mentor team member. ESSENTIAL FUNCTIONS: 1. Represent RA to drive innovation on new product development projects ...

      1. Director/Senior Director, Biologics Development (Dublin, Ireland or Philadelphia, PA, US) at Jazz Pharmaceuticals

        In addition, the Senior Director will be responsible for independent action on a variety of initiatives ranging from support of regulatory filings and...

      2. K-12 Data and Policy Analyst at The Education Trust

        Work collaboratively with the Government Affairs and Communications team to monitor federal, state, and local K-12 policy activities and quickly respond to...

      3. Quality Assurance Specialist at PixarBio Corporation

        The Quality Assurance Specialist will report to VP Regulatory Affairs. PixarBio is searching for a qualified, highly motivated individual to develop and...

      4. Account Executive at Tuv America

        TÜV SÜD Canada Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has immediate openings at our facility in Laval,...

      5. District Business Leader - Addiction - Northwest at Alkermes, Inc.

        Strong understanding of healthcare regulatory and enforcement environments and demonstrated ability to work cross-functionally....