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Director, CMC Regulatory Affairs
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Associate Director, CMC Regulatory - Cambridge, MA, United States - Sarepta Therapeutics
Description
Co-lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives.
Develops and delivers on fit for purpose high quality documentation (e.g., IDEs, IVDR documents, PMAs, reports, and correspondences) to support successful global Health Authority interactions.
Facilitates risk identification & mitigation strategies. Oversees activities of junior regulatory personnel. Manages contractual and budgetary responsibilities with best business practices.Primary Responsibilities Include:
Preparation of submissions, supplements, and correspondence with regulatory authorities, including Performance Evaluation Applications under IVDR, requests for Study Risk Determinations and Investigational Device Exemption (IDE) applications.
Working with diagnostic partners to mutually align on co-development regulatory needs and determine regulatory paths toward development and global registration activitiesDevelops fit for purpose regulatory strategies incorporating totality of development and driving engagements that result in high value feedback from global health authorities and support Corporate objectivesRepresents Sarepta as direct contact for FDA and at global health authority meetings including a planning, preparation for and conduct of meetings with Regulatory agencies for all assigned productsInteracts across the Regulatory department and other line functions to lead team through successful engagements with Regulatory AgenciesIn collaboration with Regulatory project lead, responds to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of productsEnsures that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, and scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency reviewGuides clinical and nonclinical study teams to implement appropriate regulatory strategiesCoordinates and manages regulatory activities required for submissions to regulatory agencies for assigned productsMaintains knowledge of relevant evolving regulation and guidanceGlobal Regulatory Teams - lead team to establish and implement multi-disciplinary regulatory strategyWorks on complex issues where analysis of situations or data requires an in-depth knowledge of the companyWorks on objectives that have critical impact on functional area and the organizationEstablishes and assures adherence to budgets, schedules, work plans, and performance requirementsErroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activitiesExpected to present and contribute to presentations at governance committees including Research and development Committee, the Executive Committee, and the Communications CommitteeDesired Education and Skills: Experience in device or drug/device combination product regulatory framework, global experience is preferredKnowledge of product labeling for devicesDemonstrated knowledge of drug development process.
Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.Experience with preparing regulatory submissions and briefing packages for regulatory meetingsPersonal leadership, with an ability to bring divergent views together, agree on common objectives and engenders enthusiasm even in challenging circumstances.
Leading without authorityAble to effectively communicate on regulatory topics both internally and externallyShows flexibility and is open to adaptable to changeBS or equivalent with 10+ years of related experiencePrior regulatory affairs experience in major markets is expected#LI-RemoteThis position is remote.
However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges.The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
SummaryLocation:
Cambridge, MAType:
Full time
