Regulatory Affairs Senior Manager, Operations Jobs | Glassdoor

Regulatory Affairs Senior Manager, Operations Jobs

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  • 2.3
    Keryx Biopharmaceuticals – Boston, MA
    Est. Salary $118k-$189k
    6 days ago 6d
    with Clinical Operations and other internal and external functions including Pharmacovigilance, Regulatory Affairs, Quality, Medical… safety reports, briefing documents, INDs, NDAs, and other regulatory documents Assist with budgeting activities (for clinical…
  • Commonwealth Medicine | Office of Clinical Affairs – North Quincy, MA
    Today 9hr
    units in the Office of Clinical Affairs and other state agencies. MAJOR RESPONSIBILITIES: Manage unit Nurse Reviewer, Care Coordination… direction of the MassHealth Senior Medical Director or his/her designee, the Nurse Manager manages the Chronic Disease and Rehabilitation…
  • 2.6
    Accuray – Sunnyvale, CA
    Est. Salary $117k-$180k
    6 days ago 6d
    analysis techniques. ≥ 5 years of experience in Regulatory Affairs/Quality/Regulatory Compliance activities with prior managerial… or AdvaMed RA/QA Certification ASQ Certified Manager of Quality / Operation Excellence (CMQ/OE) ASQ Certified Quality Engineer…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    4 days ago 4d
    work closely with the regulatory affairs, medical science, clinical operations development, medical affairs, and translational science… responsibilities independently, and to have external interactions with regulatory authorities, cooperative groups, external experts, and vendors…
  • 3.5
    Duke Clinical Research Institute – Durham, NC
    Est. Salary $72k-$104k
    12 days ago 12d
    groups and contacts such as business development, regulatory affairs, regulatory agencies, legal, compliance, risk management, audit… DCRI partners. Will provide senior management with updates and status of responses to regulatory inspections. Provide subject…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    10 days ago 10d
    strategy and manage business performance at a corporate level with P&L accountability Demonstrated success at senior/executive level… experiences in marketing, market research, sales, and/or medical affairs is important including experience in the hospital channel…
  • 2.6
    Accuray – Madison, WI
    Est. Salary $37k-$56k
    7 days ago 7d
    accordance with regulatory requirements. 2. REPORTING TO/DEPARTMENT: Reports to the (Senior) Manager Manufacturing –… production/servicing of the product. •Interface and support regulatory affairs as required to help ensure production processes and facilities…
  • 3.3
    Shire Pharmaceuticals LLC – Exton, PA
    4 days ago 4d
    Assurance, Regulatory Compliance, Pharmaceutical Sciences, Global Pharmaceutical Technology, Global Regulatory Affairs. External… Surveillance Senior Specialist works closely and collaboratively with the Product Quality Management Leads, Technical Operations and other…
  • 5.0
    Audentes Therapeutics – San Francisco, CA
    12 days ago 12d
    collaborative relationships with Clinical Operations, Regulatory Affairs, Medical Affairs, Physicians, other developmental group… analyses to support regulatory filings Supports development and analysis of Medical Affairs-driven outcome studies…
  • 5.0
    Blueprint Medicines – Cambridge, MA
    Est. Salary $76k-$143k
    11 days ago 11d
    US business. Work with field personnel (medical affairs, sales and managed markets) to identify and address key account organizational… strategy and tactics. Directly manage the US marketing budget for BLU-285. Understand the regulatory environment and comply with…
  • 3.3
    Shire Pharmaceuticals LLC – Lexington, MA
    13 days ago 13d
    Legal, Regulatory Affairs, Global Medical Affairs, Pharmacovigilance, Risk Management and Compliance, Commercial Operations, Global… our pipeline candidates. The senior director will report to the Head, Communications & Public Affairs team and will partner with…
  • 3.3
    Sunovion – Marlborough, MA
    Est. Salary $78k-$167k
    12 days ago 12d
    Institutional Sales, Government Affairs, Legal, Regulatory, Commercial Analytics, Medical Affairs, Field Sales Management, and Sales… the development of sound managed markets business strategy. • Collaborate closely with Medical Affairs/HEOR to ensure payer related…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $115k-$298k
    10 days ago 10d
    long range plans. Work closely with Medical Sciences, Regulatory Affairs, and Commercial to set team strategies through the Program… limited to: medical, science, clinical operations, manufacturing, business, legal & regulatory to accelerate overall drug-development…
  • 3.0
    Catalent Pharma – Madison, WI
    Est. Salary $73k-$122k
    12 days ago 12d
    , Manufacturing, Process Development, Facilities, and Regulatory Affairs. Provides technical assistance and training for personnel… assure that operations at Catalent meet client requirements and cGMP regulations via Quality Control staff. The Manager will ensure…
  • 4.8
    Jounce Therapeutics – Cambridge, MA
    Est. Salary $115k-$162k
    19 days ago 19d
    create innovative regulatory strategies for targeted biologics to treat cancer. Furthermore, the RA Senior Manager will represent… advanced degree highly preferred) Minimum of 7 years of regulatory affairs experience in the biopharmaceutical industry Experience…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    18 days ago 18d
    other stakeholders including Clinical Development Teams, Regulatory Affairs, Licensing and Marketing to better understand and fully… functional groups and departments (i.e., Clinical, Regulatory, Quality, Medical Affairs) and corporate partners Experience with…
  • 4.1
    Genentech – South San Francisco, CA
    Est. Salary $120k-$157k
    28 days ago 28d
    Marketing, Government Affairs, Managed Care Organization, Commercial Business Operations, US Medical Affairs, Regulatory, Legal, and others… Hiring / Find A Job Industry Analytics Senior Manager/Manager Biosimilars - Market Analysis and Strategy South…
  • 4.2
    Glotel Inc. – Irving, TX
    EASY APPLY
    25 days ago 25d
    Legal, Regulatory, and Government Affairs on local, state, and federal legislation impacting right of way use. Manages, coordinates… equitable and nondiscriminatory provisions of federal law. Regulatory experience and able to read/decipher contracts Strong communication…
  • 2.5
    Venable LLP – Washington, DC
    Est. Salary $118k-$200k
    6 days ago 6d
    complex litigation, intellectual property, regulatory matters, and government affairs. Additional information can be found at www.Venable.com… capital expenditure financing alternatives, operational decisions and regulatory initiatives. Optimizing the handling of firm…
  • 2.9
    Southern California Edison – Rosemead, CA
    Est. Salary $102k-$146k
    4 days ago 4d
    stakeholders, and regulatory agencies (CPUC and CAISO). Essential job duties for the Senior Project Manager are: Responsible… required regulatory compliance filings and reports, including all appropriate documentation. Supports the Senior Manager of Policy…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $59k-$128k
    24 days ago 24d
    portfolio of products. Partner with Quality Assurance and Regulatory Affairs to ensure that high quality standards are maintained and… member of the Technical Operations group, the successful candidate will work closely with the Senior Director, Pharmaceutical…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $180k-$228k
    26 days ago 26d
    departments including marketing, market research, legal, regulatory, medical affairs, segment marketing, corporate compliance, consumer… Ability to effectively manage multiple competing priorities · Strong understanding of legal and regulatory environment in pharmaceutical…
  • 3.6
    Foundation Medicine – Cambridge, MA
    25 days ago 25d
    stakeholders including BD peers, the Biopharma Operations team, R&D, Regulatory Affairs, and Finance. As a member of the Biopharma… . Interact closely with the Biopharma Operations team to manage day-to-day operational and tactical aspects of pharma/biotech…
  • 2.8
    NantWorks – Culver City, CA
    13 days ago 13d
    incumbent will support Clinical Affairs, Regulatory Affairs, and the Research and Development teams and is responsible for the preparation… Position Overview: The Senior Manager, Regulatory Writing is a full-time, Culver City, CA office-based position. The incumbent…
  • 3.2
    Glanbia Performance Nutrition – Downers Grove, IL
    Est. Salary $102k-$142k
    13 days ago 13d
    Global Country Managers Support specified customer/supplier initiatives with other departments Integrate regulatory, environmental… closely with leads of the other R&D functions, Operations, Quality, Legal/Regulatory, Purchasing, etc., to align on business objectives…
  • 3.6
    Foundation Medicine – Cambridge, MA
    28 days ago 28d
    peers, Strategic Alliances team, R&D, Regulatory Affairs, and Finance to forecast and manage timelines, resource plans, critical… needs and new product opportunities Build relationships with senior-level R&D executives at partner organizations that enable identification…
  • 3.9
    S E C Recruitment Limited – Bayou Geneve, LA
    1 days ago 20hr
    Clinical Regulatory Affairs, Regulatory Affairs Manager, Regulatory Affairs Senior Manager, Senior Regulatory Affairs Manager, Regulatory… Regulatory Affairs Management, Reg Affairs, Reg Affairs Manager, Regulatory Affairs Coordinator, Regulatory Affairs Consultant, Principal…
  • 3.3
    PAREXEL – United States
    4 days ago 4d
    Services, Technical Support, Product Management, Sales and Regulatory Affairs as needed. Attend conferences and educate internal team… opportunity to join PAREXEL's Regulatory Outsourcing Services (PROS) Team as a Senior Regulatory Associate. We are seeking a highly…
  • 3.1
    American Institute of CPAs – Washington, DC
    14 days ago 14d
    years’ relevant experience including operations of federal or state legislative/regulatory affairs · Previous experience with… as well as other State Regulatory and Legislative Affairs team members. · Achieve team operational plan goals by coordinating…
  • 4.0
    Sangamo Therapeutics – Richmond, CA
    Est. Salary $99k-$214k
    17 days ago 17d
    Director/Senior Director, Regulatory Affairs Manager: Vice President, Regulatory Affairs Department: Regulatory Affairs… Director/Sr. Director Regulatory Affairs, is responsible for combining knowledge of scientific, regulatory and business issues to…
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