Executive Lead, Gene Therapy Regulatory Strategy
Dormont Manufacturing Company
Lilly is seeking a Senior Director, Regulatory Affairs to lead regulatory strategies for gene-editing programs in Boston. This role requires extensive experience in regulatory affairs, focusing on planning and compliance for new pharmaceutical products. The ideal candidate will have a Bachelor's degree, over 10 years in the biotech industry, and a strong understanding of domestic and international regulations. This position involves significant interaction with regulatory bodies and requires excellent communication and project management skills. #J-18808-Ljbffr
- ...Initial Therapeutics, Inc. is seeking an Associate Vice President of Regulatory Strategy to lead the regulatory efforts for gene-editing therapies. This role entails developing global regulatory strategies while managing day-to-day regulatory activities and ensuring compliance...Regulatory
- ...Lilly is seeking an Associate Vice President, Regulatory Strategy in Boston. This pivotal role will lead regulatory strategies for gene editing therapies and oversee all regulatory activities. The ideal candidate will possess over 15 years of relevant experience, holding...Regulatory
$295k - $372.87k
...advancing a portfolio of gene therapy candidates targeting rare... ...President of Managed Markets to lead the development and execution of the company’s... ...and Global market access strategy. This individual will play... ...cross-functionally with Regulatory, Legal, Medical Affairs,...RegulatoryTemporary workFlexible hours$187.5k - $275k
...is seeking a Senior Director of Regulatory Strategy in Boston, MA. This role involves leading the planning and implementation of regulatory strategies for gene-editing programs, managing submissions... ...complex biologics and gene therapy. The expected salary ranges from...Regulatory$180k - $235k
...in Boston, MA, is seeking an Associate Director/Director of Regulatory Strategy. This role is pivotal in managing regulatory activities for... .... Ideal candidates will have substantial experience in gene therapy within the biotech field and 5+ years in regulatory affairs...Regulatory- ...A leading biopharmaceutical company is seeking an Associate Director for Global Regulatory Affairs in Boston. This role involves leading regulatory strategies for complex projects, ensuring compliance with... ...delivering transformative therapies and offers a hybrid work...Regulatory
$300k - $330k
...individual who seeks to lead from the front and is... ...a lasting impact. The Executive Director, Program Lead... ...of transformative therapies to patients who need them... ...planning and mitigation strategies, delivering solutions... ...including navigating regulatory pathways, with an eye...RegulatoryWork at officeRemote work- ...of Translational Medicine to lead and integrate various functions... ...into transformative therapies. Key responsibilities include... ...defining and leading translational strategies, managing interdisciplinary teams... ...and ensuring alignment with regulatory objectives. The ideal...Regulatory
- ...committed to developing therapies that make a meaningful... ...Could you be our next Executive Director, Regional... ...Innovation and Due Diligence Lead? The job is in our... ...for shaping strategies that accelerate external... ...technology, and cell and gene therapy to support continued...Work at officeLocal areaWorldwide3 days per week
$297.59k - $360.6k
...breakthroughs in cell therapy, this is work that transforms... ...BMS is hiring an Executive Director, Global... ...will be responsible for leading a portion of the Pumitamig... ..., integrated asset strategies to achieve ambitious near... ..., and evolving regulatory, patient advocacy and...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...Vice President, Cell & Gene Therapy About the Company Global... ...commercial background to lead the global strategy, performance, and operations... ...for defining and executing a data-driven business strategy... ...ensuring compliance with regulatory, quality, and industry standards...Regulatory
- ...Vice President, Cell & Gene Therapy About the Company Internationally... ...will be tasked with leading the global strategy, commercial performance,... ...therapy modalities. This executive will be responsible for... ...ensuring compliance with regulatory and quality standards, and...Regulatory
$327.1k - $399.9k
...Vice President, Gene Editing Core... ...Gene Editing Core leads a highly cross-functional... ...advance genome editing therapies. This role will... ...the planning, execution, and delivery of projects... ...role will develop strategy, implement, and... ...with clinical, regulatory, and product development...RegulatoryLocal area$260k - $296k
...marketed medicines and a leading pipeline in... ...innovation in RNA therapies in addition to advancing... ...new approaches in gene editing to provide... ...your career! EXECUTIVE DIRECTOR, US VALUE... ..., and value strategy across Ionis’ commercial... ...Affairs, HEOR, Regulatory, Government Affairs...RegulatoryRemote workShift work$71.25k - $161.7k
...pharmaceutical industry. Responsibilities include reviewing analytical data, managing laboratory projects, and ensuring adherence to regulatory requirements. The expected compensation ranges from $71,250 to $161,700, and the role requires on-site presence in our Boston lab...Regulatory$228k - $313.5k
...Cambridge, MA USA Executive Director, CMC (Chemistry,... ...driving portfolio‑level CMC strategy and execution across... ...leadership team and lead CMC functions—... ...Product Development and Regulatory CMC. Accountability for... ...nucleic acids, cell or gene therapies. Demonstrated track record...RegulatoryContract work$228k - $313.5k
...We are seeking an Executive Director, CMC (Chemistry... ...driving portfolio-level CMC strategy and execution across... ...leadership team. Lead CMC functions including... ...Product Development and Regulatory CMC. Accountability... ...nucleic acids, cell or gene therapies Demonstrated track...RegulatoryContract work- ...Takeda Pharmaceuticals International GmbH is seeking a Head of Regulatory Legal in Cambridge, Massachusetts. This role involves developing and leading the legal strategy for Global Quality, R&D, and Regulatory Affairs. The candidate will provide high-level legal counsel...Regulatory
- ...Therapeutics is a leading biopharmaceutical... ...developing transformative gene-based medicines... ...CRISPR-based therapy, approved for eligible... ...Development, the Executive Director will... ...clinical development strategy, mentoring of clinical... ...books, and other regulatory documents and...RegulatoryRemote work
$368.95k
...The Medical Lead will design, execute, and interpret clinical... ...input to the long-term strategy for these global development... ...(CDST) for these therapies where your dual... ...support of the company's regulatory submissions,... ...Knowledge and experience in gene editing/therapy is...RegulatoryTemporary workRemote work$249.97k - $388.13k
...Position Summary: The Executive Director, Global Value Evidence Lead, is a strategic leader responsible for driving the global value evidence strategy across the company's portfolio. This senior... ...initiatives to support regulatory, HTA, and payer submissions, and...RegulatoryTemporary workLocal areaFlexible hours$240k - $270k
...If you're passionate about gene therapy and its ability to enhance the... ...Scope of the Role As Executive Director, Technical Operations... ..., analytics, quality, regulatory, and supply - Guide late-stage... ...launch readiness, translating strategy into executable CMC plans...RegulatoryRemote workFlexible hours$330k - $365k
...vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The... ...You will own the medical strategy, lead study design and execution, and serve as the clinical... ...and adherence to GCP and regulatory standards. Interpret and communicate...RegulatoryTemporary workFlexible hours- ...we launched our fourth therapy and the first ever gene therapy to treat... ...Global Medical Affairs Strategy and Field, the MSL Team Lead is responsible for the... ...Strategy PlansLeads and executes autonomously with confidence... ...with industry and regulatory compliance guidelines;...Regulatory
$311.2k
...Executive Medical Director, Global Medical Lead - HEME page is loaded## Executive Medical Director, Global Medical... ...Hematology within the Global Medical Strategy group. This individual will be... ...with corporate policies and regulatory requirements. • Determine staffing...RegulatorySummer workRemote workFlexible hours2 days per week- ...Executive Director, Lead Negotiator About the Company Globally acclaimed financial services... ...negotiation-related queries, driving strategy and execution across negotiation workflows... ...ensuring the team's compliance with regulatory changes. Applicants must have a...RegulatoryContract work
$212k - $333.19k
...biotech and the resources of a leading pharmaceutical company. It is... ...design, externalized wet lab execution, and a direct line to... ...articulate, and evolve the program strategy; build the medicine vision and... ...business acumen including regulatory and commercial awareness Additional...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote work$238k - $374k
...biotech and the resources of a leading pharmaceutical company. It is... ...or externalized wet lab execution, and a direct line to governance... ...articulate, and evolve the program strategy for antibody, bispecific,... ...business acumen including regulatory (BLA/MAA pathway) and commercial...RegulatoryMinimum wageTemporary workLocal areaRemote work$180k - $235k
...limitations of existing therapies and enable next-... ...in vivo delivery and gene-regulating technologies... ...unmet needs. nChroma’s lead candidate, CRMA-1001,... ...Associate Director/Director, Regulatory Strategy will oversee the... ...management, coordination and execution of regulatory...RegulatoryLocal area- ...Role : Executive Director, Regulatory Affairs Location: Boston, MA (Hybrid)... ...on developing innovative therapies for patients with cancer and... ...to shape global regulatory strategy, influence development decisions... ...Key Responsibilities Lead global regulatory strategy...RegulatoryRemote work
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