Regulatory Affairs Manager Jobs in Waltham, MA | Glassdoor
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Regulatory Affairs Manager Jobs in Waltham, MA

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  • 3.5
    EMD Serono – Billerica, MA
    Est. Salary $120k-$167k
    6 days ago 6d
    regulation. Your role: The regulatoryaffairs senior manager role is to assist the Global Regulatory Lead and/or the Regional lead… business of Merck KGaA, Darmstadt, Germany. Global RegulatoryAffairs (Development) is actively involved actively involved in…
  • 4.0
    Tesaro – Waltham, MA
    Est. Salary $97k-$140k
    19 days ago 19d
    Manager, RegulatoryAffairs Do you have the passion to join a young global biopharmaceutical whose sole mission is to improve… ; including 1-3 years of RegulatoryAffairs experience • Exposure to CMC and international regulatory issues a plus • Excellent…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $120k-$192k
    27 days ago 27d
    mitigate risks. At least 8-10 years of experience in RegulatoryAffairs related development of pharmaceuticals; preference for… Orphan). Provide support for regulatory review of publications and clinical trial materials Manage contract staff and vendors as…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $92k-$156k
    21 days ago 21d
    Director of CMC RegulatoryAffairs to join our growing and dynamic team. Reporting to the Director of RegulatoryAffairs, the Associate… Associate Director of CMC RegulatoryAffairs will be the leader in interactions with the Regulatory Authorities as necessary to support…
  • ClinLinks – Waltham, MA
    7 days ago 7d
    Any interest in an opportunity for a newly created RegulatoryAffairsManager, focused on strategy, with a financially strong and…
  • 4.3
    Smith Hanley Associates – Westborough, MA
    6 days ago 6d
    Occasionally Senior Manager Global RegulatoryAffairs CMC Screening Questions 1.Does candidate have 3-5 years regulatory experience? 2… Senior Manager Global RegulatoryAffairs CMC Position Description Location: Westborough, Massachusetts (near intersection of 495…
  • 2.6
    Syneron Candela – Wayland, MA
    Est. Salary $78k-$121k
    NEW
    Job Description The Manager, RegulatoryAffairs is responsible for generating and submitting all the regulatory and registration… products. General Responsibilities: Manages the RegulatoryAffairs activities for Syneron Candela. The primary responsibilities…
  • The Southwind Group – Waltham, MA
    Est. Salary $66k-$105k
    13 days ago 13d
    plans for assigned products/product lines. Manages assigned RegulatoryAffairs devices personnel. Hire, train and develop… Our Regulatory team participates in all new product development teams. In some companies, RegulatoryAffairs is just another…
  • 4.3
    bluebird bio – Cambridge, MA
    Est. Salary $80k-$103k
    21 days ago 21d
    or Senior Business Systems Analyst, IT R&D Systems - RegulatoryAffairs. Reporting to the Associate Director of IT R&D, the primary… with the Regulatory Ops Business Owner to provide support in managing both ongoing and future projects within the Regulatory Affairs…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    Est. Salary $123k-$177k
    5 days ago 5d
    inspiring, bold mission. As a Manager, Emerging Markets Regulatory Affairsworking on theGlobal RegulatoryAffairs team, you will be empowered… charge of your future at Takeda. Join us as a Manager, Emerging Markets RegulatoryAffairs in ourCambridge, MAoffice. Here, everyone…
  • 5.0
    HireTalent – Cambridge, MA
    Est. Salary $56k-$103k
    NEW
    highest ethical standards and comply with applicable legal and regulatory records management requirements. He or she will support the… Additionally, the Senior Associate II works with the Senior Manager, Records Methodology & Guidance to support Global Development…
  • 3.9
    Olympus Corporation of the Americas – Waltham, MA
    Est. Salary $107k-$202k
    NEW
    Executive Director, Quality and RegulatoryAffairs (Exec Dir QARA), will oversee the Quality, Regulatory and Environmental Health and… req ID 2631BR Posting Title Executive Director, RegulatoryAffairs & Quality Assurance Company URL Olympus Corp of the…
  • 3.5
    Alkermes – Waltham, MA
    Est. Salary $61k-$95k
    30+ days ago 30d+
    meetings and present the RegulatoryAffairs perspective to the product team while working with teams to manage priorities and meet… current regulatory knowledge; Participate in RegulatoryAffairs initiatives aimed at improving internal regulatory standards…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    NEW
    guidelines for electronic submissions. Provides support to RegulatoryAffairs and other project stakeholders in the creation of submissions… impact submission timelines and goals. Assists the regulatoryaffairs liaisons in the determination of submission strategy.…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $120k-$192k
    17 days ago 17d
    issues and mitigate risks. 5+ years of experience in RegulatoryAffairs related to development of pharmaceuticals with a minimum… Serve as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all…
  • 4.1
    Integrated Resources – Waltham, MA
    Est. Salary $63k-$101k
    13 days ago 13d
    Job Title: Manager, RegulatoryAffairs CMC Location: Waltham, MA Duration: 12 Months Job Description: This position… Responsible for implementing regulatory strategies, including filing of all appropriate regulatory submissions for assigned programs…
  • 3.8
    Ironwood Pharmaceuticals – Cambridge, MA
    Est. Salary $140k-$200k
    6 days ago 6d
    description: The Manager of RegulatoryAffairs participates in the development and implementation of regulatory strategy for assigned… registration, and post marketing requirements (PMRs). The RegulatoryAffairsManager will represent the department on multidisciplinary…
  • 3.6
    ImmunoGen – Waltham, MA
    Est. Salary $109k-$157k
    15 days ago 15d
    in RegulatoryAffairs in development programs for personalized medicines. This individual will develop a broad regulatory experience… clinical trial programs. Job responsibilities: Managesregulatory global clinical/nonclinical submission plans for early…
  • 3.0
    Fresenius Medical Care – Waltham, MA
    Est. Salary $87k-$135k
    9 days ago 9d
    plans for assigned products/product lines. Manages assigned RegulatoryAffairs devices personnel. Hire, train and develop staff… Our Regulatory team participates in all FMCNA new product development teams. In some companies, RegulatoryAffairs is just…
  • 4.5
    Advanced Clinical – Cambridge, MA
    Est. Salary $152k-$204k
    27 days ago 27d
    in RegulatoryAffairs; ideally 7 plus years in the biotech industry Sound knowledge and experience in RegulatoryAffairs and… Director of RegulatoryAffairs. This position is located in Cambridge, MA. Reporting to the Senior Vice President of Regulatory Affairs…
  • 3.8
    Boston Children's Hospital – Boston, MA
    Est. Salary $86k-$134k
    NEW
    Title Sr. Compliance & RegulatoryAffairsManager Department Research-Clinical Research Core Programs Job Posting Description… lives. Yours included. The Senior Compliance and RegulatoryAffairsManager will be responsible for: Independently leading the…
  • 4.1
    Tetraphase Pharmaceuticals – Watertown, MA
    Est. Salary $73k-$106k
    21 days ago 21d
    The Manager, RegulatoryAffairs will be responsible for managing all operational aspects of preparing submissions to regulatory… experience preferred A minimum of 5-7 years’ experience in regulatoryaffairs within the biopharmaceutical industry Experience…
  • Alere Accountable Care Solutions – Waltham, MA
    13 days ago 13d
    patients and communities. The Opportunity The RegulatoryAffairs Senior Specialist is a newly created function and is… global team. Reporting into the Associate Director RegulatoryAffairs and with a dotted line into the site, this role is directly…
  • 4.0
    Tesaro – Waltham, MA
    Est. Salary $118k-$163k
    10 days ago 10d
    biostatistics, medical writing, drug safety, regulatoryaffairs, legal, clinical supply, medical affairs and scientific R&D TESARO… Senior Manager, Medical Affairs Research Do you have the passion to join a young global biopharmaceutical whose sole mission…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    Est. Salary $122k-$176k
    7 days ago 7d
    inspiring, bold mission. As a Manager, Global RegulatoryAffairs, CMC working on the Global RegulatoryAffairs team, you will be empowered… charge of your future at Takeda. Join us as a Manager, Global RegulatoryAffairs, CMC in our Cambridge MA office. Here, everyone…
  • 4.3
    bluebird bio – Cambridge, MA
    Est. Salary $81k-$138k
    22 days ago 22d
    experience in CMCfocused RegulatoryAffairs preferably for biologics Recent experience with CMCrelated regulatory interactions and BLA… collaboration with regulatory, quality and CMC colleagues Manage, develop, and build a team of experienced professionals in a…
  • 3.3
    Fresenius Medical Care - North America – Waltham, MA
    Est. Salary $77k-$121k
    10 days ago 10d
    plans for assigned products/product lines. Manages assigned RegulatoryAffairs devices personnel. Hire, train and develop staff… Our Regulatory team participates in all FMCNA new product development teams. In some companies, RegulatoryAffairs is just…
  • 3.5
    Commonwealth Care Alliance – Boston, MA
    Est. Salary $45k-$75k
    9 days ago 9d
    programs. This role contributes towards the overall RegulatoryAffairs and Compliance infrastructure at CCA, including participation… follow-up of CCA’s Compliance Risk Assessment process. Track RegulatoryAffairs and Compliance Department follow-up of compliance risks…
  • 3.4
    Biogen – Cambridge, MA
    Est. Salary $134k-$179k
    NEW
    Global Development Operations with emphasis on Regulatory Operations, RegulatoryAffairs. Develop, communicate, and execute on a… External Posting Title Associate Director RegulatoryAffairs IT Job Description Biogen has one of the most exciting pipelines…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $92k-$134k
    24 days ago 24d
    and Managed Care Information Manager to join our growing Medical Affairs team. The Global Medical Information and Managed Care… Global Medical Information and Managed Care Information Manager, Medical Affairs Location Agios Pharmaceuticals…
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