Regulatory Affairs Director Jobs in Cambridge, MA | Glassdoor
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Regulatory Affairs Director Jobs in Cambridge, MA

  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $120k-$192k
    4 days ago 4d
    mitigate risks. At least 8-10 years of experience in RegulatoryAffairs related development of pharmaceuticals; preference for… and submission of regulatory documents maintaining compliance with regulatory requirements. Prepare regulatory agency meeting requests…
  • RaNA Therapeutics – Lexington, MA
    EASY APPLY
    Est. Salary $125k-$322k
    18 days ago 18d
    rigorous individual to join our team as Director or Senior Director of RegulatoryAffairs. This position offers opportunities to… highly desired At least 10 years of broad industrial regulatoryaffairs experience is required Demonstrated success in guiding…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $92k-$156k
    25 days ago 25d
    Associate Director of CMC RegulatoryAffairs to join our growing and dynamic team. Reporting to the Director of Regulatory Affairs… Affairs, the Associate Director of CMC RegulatoryAffairs will be the leader in interactions with the Regulatory Authorities as necessary…
  • 4.5
    Advanced Clinical – Cambridge, MA
    Est. Salary $152k-$204k
    4 days ago 4d
    to the Senior Vice President of RegulatoryAffairs, the Senior Director of RegulatoryAffairs will work with a cross-functional… professional to join a well-known client’s team as Senior Director of RegulatoryAffairs. This position is located in Cambridge, MA. Reporting…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $132k-$217k
    17 days ago 17d
    marketed and to-be marketed drugs, and serve as a the lead regulatoryaffairs representative on the oversight committees for our lead… minimum of five to seven years related experience in RegulatoryAffairs-Advertising and Promotion At least five (5) years of…
  • 5.0
    Blueprint Medicines – Cambridge, MA
    Est. Salary $123k-$167k
    4 days ago 4d
    Summary: The Director of RegulatoryAffairs will have primary responsibility for developing global regulatory strategies to advance… Reporting to the Head of RegulatoryAffairs, this individual will provide strategic input and operational regulatory support to cross-…
  • 3.5
    EMD Serono – Billerica, MA
    Est. Salary $123k-$166k
    10 days ago 10d
    attention to detail Strong awareness of current trends in regulatoryaffairs Ability to think & plan strategically What we offer… of the regional or global regulatory strategy for a key indication (as outlined with the Regulatory team in accordance with the…
  • 2.9
    Oxford Immunotec, Inc. – Norwood, MA
    Est. Salary $133k-$181k
    NEW
    and laboratory services. RegulatoryAffairs (RA) responsibility for delivering Babesia blood screening BLA approvals. RA… products and services Regulatory activities within Oxford Immunotec Ltd. The position will also have US regulatory management and supervision…
  • 4.1
    Alnylam Pharmaceuticals, Inc. – Cambridge, MA
    Est. Salary $168k-$227k
    30+ days ago 30d+
    President of Regulatory, the Director of RegulatoryAffairs will work with a cross-functional team to implement regulatory strategy… areas in RegulatoryAffairs in the biotech or pharmaceutical industry. Sound knowledge and experience of RegulatoryAffairs and associated…
  • 3.9
    Momenta Pharmaceuticals – Cambridge, MA
    Est. Salary $127k-$172k
    24 days ago 24d
    Job Description We are seeking an experienced Director, RegulatoryAffairs. The successful candidate will provide expertise… policies related to regulatoryaffairs. Prepares Regulatory Standard Operating Procedures and provides regulatory review of SOPs from…
  • 3.6
    AstraZeneca – Cambridge, MA
    Est. Salary $93k-$157k
    5 days ago 5d
    senior regulatory role with a world-leading pharmaceutical company. At AstraZeneca, we’re looking for RegulatoryAffairs Director… experience of regulatory drug development including product approvals/launches Expert knowledge of regulatoryaffairs within one…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $120k-$192k
    21 days ago 21d
    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…
  • 4.3
    bluebird bio – Cambridge, MA
    Est. Salary $80k-$103k
    25 days ago 25d
    Business Systems Analyst, IT R&D Systems - RegulatoryAffairs. Reporting to the Associate Director of IT R&D, the primary function of… with the Regulatory Ops Business Owner to provide support in managing both ongoing and future projects within the Regulatory Affairs…
  • 4.5
    Vericel – Cambridge, MA
    Est. Salary $128k-$172k
    19 days ago 19d
    Position Summary: The Associate Director, RegulatoryAffairs develops regulatory objectives, advice, and strategy in alignment… Basic Qualifications: 7+ years of experience in RegulatoryAffairs strategy for pharmaceutical, biotech, or medical device…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $71k-$189k
    10 days ago 10d
    highly visible role that is responsible for leading medical affairs brand lifecycle strategies and real-life data generation activities… lifecycle and tactical brand plans as they pertain to Medical Affairs activities, including provision of strategic guidance and leadership…
  • 3.0
    Ionis Pharmaceuticals – Cambridge, MA
    Est. Salary $142k-$191k
    7 days ago 7d
    ASSOCIATE DIRECTOR, REGULATORYAFFAIRS The Associate Director, RegulatoryAffairs will help develop regulatory strategy and… , reporting to the Senior Director, RegulatoryAffairs. The Associate Director, RegulatoryAffairs will work within cross functional…
  • 4.3
    bluebird bio – Cambridge, MA
    Est. Salary $81k-$138k
    27 days ago 27d
    experience in CMCfocused RegulatoryAffairs preferably for biologics Recent experience with CMCrelated regulatory interactions and BLA… is looking for a Director/Sr. Director, Regulatory Science, CMC who will be responsible for providing regulatory CMC strategic leadership…
  • 3.9
    Olympus Corporation of the Americas – Waltham, MA
    Est. Salary $107k-$202k
    7 days ago 7d
    - The Executive Director, Quality and RegulatoryAffairs (Exec Dir QARA), will oversee the Quality, Regulatory and Environmental… Auto req ID 2631BR Posting Title Executive Director, RegulatoryAffairs & Quality Assurance Company URL Olympus Corp…
  • 4.1
    Akebia Therapeutics – Cambridge, MA
    Est. Salary $123k-$167k
    11 days ago 11d
    its Regulatory team to support late phase clinical assets and is searching for a Director/Sr. Director, RegulatoryAffairs to support… President, RegulatoryAffairs Required Skills Design well-informed global regulatory strategies Represent Regulatory Affairs…
  • 5.0
    HireTalent – Cambridge, MA
    Est. Salary $56k-$103k
    5 days ago 5d
    highest ethical standards and comply with applicable legal and regulatory records management requirements. He or she will support the… Cambridge,MA Job Duration: 4 months Reporting to the Director, Records Methodology & Guidance and TMF, the Senior Associate…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $75k-$164k
    5 days ago 5d
    among the different cross-functional groups, including medical affairs, HEOR, and other late-stage teams. Liaise with clinical site… study communication plans). Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    Est. Salary $146k-$197k
    27 days ago 27d
    Associate Director of CMC RegulatoryAffairs to join our growing and dynamic team. Reporting to the Director of Regulatory Affairs… Affairs, the Associate Director of CMC RegulatoryAffairs will be the leader in interactions with the Regulatory Authorities as necessary…
  • 3.4
    Biogen – Cambridge, MA
    Est. Salary $134k-$179k
    5 days ago 5d
    External Posting Title Associate DirectorRegulatoryAffairs IT Job Description Biogen has one of the most exciting pipelines… Global Development Operations with emphasis on Regulatory Operations, RegulatoryAffairs. Develop, communicate, and execute on a…
  • Voyager Therapeutics – Cambridge, MA
    EASY APPLY
    Est. Salary $66k-$114k
    5 days ago 5d
    Associate Director, RegulatoryAffairs CMC The Associate Director of RegulatoryAffairs CMC will be responsible for developing… Associate Director of Regulatory CMC will provide relevant documentation, support and rationale concerning Regulatory CMC submissions…
  • 3.4
    Takeda Pharmaceuticals – Cambridge, MA
    Est. Salary $180k-$246k
    NEW
    mission. As a Director, Global RegulatoryAffairs Biologics and New Modalities working on the Global Regulatory Affairsteam, you… charge of your future at Takeda. Join us as a Director, Global RegulatoryAffairs Biologics and New Modalities in our Cambridge…
  • 4.0
    Curis – Lexington, MA
    Est. Salary $55k-$127k
    26 days ago 26d
    Curis is seeking an Associate Director, RegulatoryAffairs to lead regulatory activities for several Curis projects. Reporting… 7-10 years of regulatoryaffairs experience Experience and knowledge in the preparation of global regulatory submissions (e.…
  • 3.1
    Sanofi U.S. – Cambridge, MA
    Est. Salary $198k-$268k
    14 days ago 14d
    TA immunology: Senior Director, Global RegulatoryAffairs The Senior Director will be leading a portion of the immunology franchise… industry experience, with at least 10 years working in regulatoryaffairs (regionally or globally). Delivery of a number of major…
  • 2.5
    Agenus – Lexington, MA
    Est. Salary $132k-$178k
    5 days ago 5d
    Agenus is currently looking to hire an Associate DirectorRegulatoryAffairs to join our team. We are looking for someone with… submissions, research regulatory issues, interaction with regulatory CRO, optimize regulatory process to improve productivity. This…
  • 3.4
    Biogen – Cambridge, MA
    Est. Salary $134k-$179k
    6 days ago 6d
    Associate Director, Global RegulatoryAffairs Job Description This Associate Director role is in the Global Regulatory CMC group… the global regulatory contact with relevant regulatory authorities •Coordinate all CMC aspects of global regulatory submissions…
  • 2.8
    Seqirus – Cambridge, MA
    Est. Salary $136k-$276k
    4 days ago 4d
    other functions in RegulatoryAffairs (e.g. Global Regulatory Leads, Regulatory CMC & Compliance, Regulatory Operations & Compliance… The RegulatoryAffairs Senior Manager, US & Regions role is a strategic role within the US and Regions regulatory team. The role…
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