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Senior Program Manager, Regulatory Affairs - 10194

Company: Simply Biotech
Location: San Diego
Posted on: June 26, 2019

Job Description:

Senior Program Manager, Regulatory Affairs- Simply BiotechOverviewAre you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.Immediate opening for a Senior Program Manager, Regulatory Affairs in San Diego, CA who possesses:Degree in Scientific Discipline and 5+ years of progressive Regulatory Affairs experience in Biotech or Pharmaceutical IndustryExperience with early development regulatory affairs (CMC, Clinical and Generalist Experience) CBER, NDA or BLA preferred experienceDomestic FDA experience required, EU preferred with authoring, coauthoring, reviewing and editing - strong regulatory writing knowledge Email resumes to or call 858.496.7758Full DescriptionThe Senior Program Manager, Regulatory Affairs (RA) will provide support to the Executive Director, RA in the development and implementation of regulatory strategies for development products. This individual will support regulatory activities, including strategy development for programs and dossier lifecycle management, and will work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of regulatory filings. This is a full-time position located at our corporate headquarters in San Diego, CA.The Selected Candidate Will Further PossessStrong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordinglyExcellent operational skills including planning, organizing, and the ability to deal effectively with a variety of personnel both internally and outside the company to drive projects to timely completionExcellent writing, communication, and interpretive skillHigh attention to detail, ability to work on multiple projects with tight deadlines and able to work independentlyPrevious cell therapy product experience and regulatory knowledge is highly preferredPrior direct interactions with Health Authorities is desirableThe Selected Candidate Will Be Responsible For The FollowingEffectively work with internal and external stakeholders to independently manage regulatory activitiesManage, author, coordinate, and review regulatory submission documents and development activities to support regulatory filings and dossier lifecycleIndependently research and interpret regulations, and provide regulatory guidance and strategy to cross-functional stakeholders; monitor clinical, non-clinical, and CMC industry and regulatory trends and be able to apply learnings and provide guidance or strategy related to such trendsLead and manage the strategy and preparation of health authority meeting materials and responses to requests for informationSupport management with development and implementation of departmental strategies and policies, and contribute to the development and implementation of regulatory strategies to mitigate risksAssure compliance with all applicable (domestic and international) regulationsMay mentor or lead other department staffOther duties as assignedWorking Conditions And Physical RequirementsMay require occasional evening and weekend workFull-time onsite work at Company's headquarters in San DiegoMay require occasional travel for training programs and meetingsFor immediate and confidential consideration, please email your resume to or call 858.496.7758More information can be found at www.simplybiotech.comSimply Biotech specializes in recruiting exclusively for the biotech Jobble

Keywords: Simply Biotech, San Diego , Senior Program Manager, Regulatory Affairs - 10194, Executive , San Diego, California

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