eBay Classifieds » All ads » Jobs » 

regulatory affairs in Boston

(1-20 of 27 ads)
View as:
Categories
  1. Global Labeling Operations Manager, Regulatory at Vertex Pharmaceuticals

    This position will interact cross-functionally with members of commercial, medical affairs, global regulatory affairs, technical operations, supply chain and...

  2. Director, Integrated Program Management-Global Medicines Development at Vertex Pharmaceuticals

    Including, but not limited to, Research, Pre-Clinical, Clinical, Manufacturing and Operations, Commercial, Regulatory, and Medical Affairs....

  3. Associate Director, CMC Regulatory Affairs at Sage Therapeutics

    5+ years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 4 years in Chemistry, Manufacturing and Control (CMC)...

  4. Director/Sr. Director, CMC Regulatory Affairs at Sage Therapeutics

    8-10 years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 4 years in Chemistry, Manufacturing and Control (CMC)...

  5. Medical Director, Cystic Fibrosis Clinical Development at Vertex Pharmaceuticals

    Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies...

    Ads
    1. Regulatory Affairs Consultants

      Regulatory Affairs Consultants ProfileEntry-level and mid-level Regulatory Affairs professionals with working knowledge of regulated industry (pharma / biopharma), robust understanding of 21 CFR 210 & 211, and proven experience with regulatory filings preparations. Qualifications· Tactical, hands-on experience with Chemistry, Manufacturing and Controls (CMC) authoring (Modules 2 and 3)· ...

    1. Medical Director, Cystic Fibrosis at Vertex Pharmaceuticals

      Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies...

    1. Pharmacovigilance / Drug Safety Consultants

      Pharmacovigilance / Drug Safety Consultants ProfileQualified Pharmacovigilance consultants with expertise in development, maintenance and improvement of Pharmacovigilance programs to achieve compliance with applicable regulatory requirements. Qualifications· Development of Pharmacovigilance programs, including writing and revision of Standard Operating Procedures (SOPs), policies, and ...

    1. Director of Regulatory Affairs at Solid GT

      Director/Senior Director Regulatory Affairs*. Act as the internal regulatory accountable individual for regulatory dossier and other regulatory submissions and...

    1. New Position Available! - Regulatory Affairs Specialist - Pharma/Biot

      How are you,This is John Liotine, I represent The Fountain Group a national staffing firm.  I am currently reaching out to you to fill a position as a Regulatory Affairs Specialist for a prominent Medical Device Corporation of ours.  This position is located in Cincinnati, OH.Details for the positions are as follows: WE ARE LOOKING FOR SOMEONE TO RELOCATE TO CINCINNATI, ONSITE INTERVIEW ...

    1. Program Manager (Pharma or Biotech) at Solid GT

      Understanding of the regulatory process for a new drug application and organization of data for regulatory interaction....

    1. Account Director - Pharma - Boston

      • Provide guidance and direction for client accounts.• Serve as “resident expert” on clients’ business, products, industry and objectives• Assume responsibility for work flow and client satisfaction• Write and present comprehensive programs• Maintain all accounts in a healthy manner that delivers fully on client expectations and commitments while maintaining profitability for Medical Dynamics ...

    1. Medical Writing Lead at EMD

      Global Regulatory Affairs – alignment around documentation required for submission. Responsible for writing overall strategic documents (IND, briefing books,...

    1. Senior Clinical Affairs Project Manage

       This position has the responsibility and authority to be a significant contributor to the overall clinical development strategy for products/therapies within the surgical business. Managing all aspects of clinical strategies, study design and development, study execution, monitoring, and addressing issues during clinical trials. Manage data analysis and clinical trial report writing, and ...

    1. Senior Manager, Regulatory Science, Process Compliance & Training at EMD

      Previous experience reviewing processes across functions of Regulatory Affairs. Professional experience in US Regulatory Affairs, (experience within multiple...

    1. 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

    1. Senior Manager/ Manager, Regulatory Affairs at EMD

      Manage the regulatory submission process from initiation to approval including management and coordination of the preparation of all regulatory documentations...

    1. Pharmacovigilance / Drug Safety Consultants

      Pharmacovigilance / Drug Safety Consultants ProfileQualified Pharmacovigilance consultants with expertise in development, maintenance and improvement of Pharmacovigilance programs to achieve compliance with applicable regulatory requirements. Qualifications·         Development of Pharmacovigilance programs, including writing and revision of Standard Operating Procedures (SOPs), policies, and ...

    1. Head of Portfolio and Program Management at Sage Therapeutics

      The individual will work collaboratively with the program teams to manage and integrate the diverse commercial activities and R&D of drug development through...

    1. Senior Development Engineer

      This position will support the Renal Care Solutions Business, with a specific focus on disposable dialysis catheters. The individual will be responsible to support and/or lead design related activities that cover all phases of the product life cycle from concept through end of life. The engineer must have the flexibility of skill and temperament to work in both new product development, and ...

    1. Sr. Director, Clinical Regulatory Strategy - North America at Vertex Pharmaceuticals

      The Senior Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs....

    1. Expert Product Registration / Product Steward 191.16CM

      :: If you meet the qualifications listed below and would like more information contact Crystal at 815-756-1221 Attach resume when responding to this posting :: The Product Steward will be responsible for proactively advising business managers and research & technology project manager on product registration and product stewardship activities. Qualifications: -BS/MS in science or chemistry ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    1. Medical Director, Phase IV Global Medical Affairs at Vertex Pharmaceuticals

      Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports...

    1. Medical Science Liaison

      MEDICAL SCIENCE LIAISON (PharmD, MD, Phd or OD)Lexington, MA Area REQUIREMENTS1+ years of experience as a Medical Science LiaisonProvide in depth scientific, clinical and educational support to external customers as well as internal clinical, sales and marketing teamsProvide scientific insight to the internal medical affairs management teamBuild and maintain strong, credible relationships ...

    1. Medical Director, US Medical Affairs, Oncology at EMD

      Medical Director, US Medical Affairs, to build, monitor, track, manage, and assist with the implementation of the US Medical Affairs strategic initiatives and...

    1. Regulatory Specialist - Medical Device

      The Medical device Regulatory Specialist will provide direct regulatory support to various projects and products, both new and existing. Responsibilities may include:Preparing regulatory registration, notification, and pre-market submission requirements, including the necessary regulatory documents.Providing regulatory support for product changes/modifications, labeling, and promotional ...

    2. Director of Education

      Our client, a higher education institution committed to student success is seeking an accomplished Director of Education responsible for building and maintaining a high performing education & academic team.  The Director of Education will be responsible for budgeting, staffing, program development, training and oversight of the academic affairs department. If you are seeking an opportunity ...

    3. Director Quality & Regulatory Assurance #5689DW

      Although this position is located in South Central, NH, relocation package offered for qualified candidates.JOB SUMMARY:The Director of Quality Assurance and Regulatory Affairs provides overall company leadership and direction to meet customer quality requirements, create, monitor and improve quality programs, reduce quality costs and maintain compliance within FDA and ISO regulations for the ...

    4. Regulatory Affairs Specialist

      The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth. The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements. Preparing international regulatory ...

    5. 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 ...

    6. 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 ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    7. 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 ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    8. 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 ...

    9. 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 ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    10. 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, Clinical Operations Program Lead at Vertex Pharmaceuticals

        Understanding all elements of clinical trial execution and regulatory reporting, ensuring studies are conducted within the parameters of GCP compliance for all...

      2. Sr. Specialist, Aggregate Reports & Risk Management at Vertex Pharmaceuticals

        Liaises with Regulatory Affairs and other functions to coordinate submission of aggregate safety reports....

      3. Senior Director, Regulatory Labeling at Vertex Pharmaceuticals

        Ten-plus (10+) years of experience in regulatory affairs in the area of global labeling development and maintenance....

      4. Sr. Director, Biostatistics at Vertex Pharmaceuticals

        Broad knowledge of statistical analysis and clinical trials design methodology and of worldwide regulatory requirements....

      5. Medical Director, Neurology at Vertex Pharmaceuticals

        Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies...