Director, Regulatory CMC - Global Cell Therapy Leadership
Legend Biotech USA, Inc.
Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. The role leads global CMC regulatory strategies for late-stage development and post-approval lifecycle management, reporting to the Regulatory Affairs head. You will provide strategic regulatory leadership to cross-functional teams, coordinate submissions with Health Authorities, and drive continuous improvement in regulatory processes while mentoring junior staff. #J-18808-Ljbffr
- Legend Biotech in Somerset, NJ, is seeking a Director of Regulatory CMC to lead global regulatory strategies for late‑stage and post‑approval programs... ...and 10+ years in biotech/pharma, including Regulatory CMC and cell/gene therapy experience. #J-18808-Ljbffr BioSpaceSuggested
- ...Legend Biotech, based in Somerset, NJ, seeks a Director of Regulatory CMC to lead global strategies for late-stage and post-approval lifecycle management, driving alignment with manufacturing and development teams. You will act as the primary Regulatory CMC representative...Suggested
$193.63k - $254.14k
...Legend Biotech is a global biotechnology company dedicated... ...advancing the next generation of cell therapy through a portfolio of... ...Biotech is seeking a Director, Regulatory CMC as part of the Regulatory... ...Provide strategic regulatory leadership to cross-functional teams,...SuggestedPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...Legend Biotech US seeks a Director, Regulatory Affairs in Somerset, NJ to lead global regulatory strategies and oversee submissions for the company’s cell therapy programs. You will interact with health authorities, coordinate cross-functional teams, and mentor staff...Suggested
- ...Miltenyi Biomedicine seeks a Director, Regulatory Affairs with a CMC focus to lead regulatory CMC activities for cell therapy programs across the US, Canada, and other regions. The role partners with Bioindustry and Biotec to craft regulatory strategies supporting clinical...Suggested
- Legend Biotech in Somerset, NJ is seeking a Director, Regulatory CMC to lead global regulatory strategies across late-stage development and post-approval... ...products. You will provide strategic regulatory leadership to cross-functional teams, interact with Health Authorities...
- ...developing oncology therapies using its... ...RAS-mutant non-small cell lung cancer, as well... ...Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing... ...Develop and lead global CMC regulatory... ...CMC. • Strong leadership, communication, and...Remote workFlexible hours
- Legend Biotech US is seeking a Director, Regulatory CMC based in Somerset, NJ, to lead global CMC regulatory strategies for late-stage and post-approval programs within Regulatory Affairs. You will influence development and manufacturing strategies and serve as the primary...
- ...PTC Therapeutics, Inc in New Jersey is seeking an Associate Director, Regulatory Affairs - CMC. This role involves leading global regulatory strategy for product development and collaboration with Technical Operations and Quality teams. The ideal candidate will have extensive...
$193.5k - $243.6k
PTC Therapeutics is a global commercial biopharmaceutical company... ...Description Summary: The Director, Regulatory Affairs - CMC is responsible for leading... ...products (eg, gene therapy) in collaboration with Technical... ...must; experience in gene/cell advanced therapy a plus....Temporary workWork at office$140.2k - $390.6k
Overview IQVIA is seeking a Director, Managed Access Regulatory Strategy to help build a... ...for investigational therapies outside of traditional clinical... ...named patient programs, global labeling considerations,... ...or full operational leadership responsibility.The Director...Full timePart timeImmediate startWorldwide- ...Eisai Inc. is seeking a Director of Global Labeling to lead the development and execution of global regulatory labeling strategies for US, EU, Growth, and Rest of World markets... ...regulatory labeling background, strong leadership, and collaboration with co-promote partners...
$152.4k - $190.5k
...at the forefront. We hold a leadership position in Duchenne muscular... ...2023, we launched our fourth therapy and the first ever gene therapy... ...the Role The Senior Manager, Global Medical Affairs Strategy, RNA... ...management of Medical/Legal/Regulatory (MLR) review processes in Veeva...- ...pushing the boundaries of cancer therapy and Autoimmune disease to... ...promotes creativity, leadership and teamwork – together we... ...Description:**Role Summary The Director, Regulatory Affairs Advertising,... ...internal subject matter expert on global labelling, Advertising &...Local areaFlexible hours
- ...offering expertise in regulatory strategy, clinical trial... ...Overview The Director, Regulatory Affairs will... ...leading or expanding new therapy ideas, as applicable.... .... Provide project leadership while maintaining sole... ...discipline (e.g., CMC); MS or PhD preferred....Work experience placement
$215k - $268.55k
...Risk and Assurance (Sr. Director) Reports to Chief... ...first in class targeted therapy for patients with blastic... ...plasmacytoid dendritic cell neoplasm (BPDCN) and to... ...Menarini entered into a global licence agreement with... ...activities. This senior leadership role is responsible for...Temporary workLocal areaFlexible hours$210k - $250k
...everything we do. As a global leader with the most... ...generation, life-changing therapies. Surrounded by a... ...Global Strategic Marketing Director is a senior strategic... ...scientific affairs, regulatory, market access, regional... ...teams, and senior leadership to develop scalable launch...Full timeRemote workWork from homeFlexible hours- ...Senior Medical Affairs leader to define and execute the global medical strategy for its cancer therapies, including post-approval activities and pipeline... ..., while serving as a strategic advisor to executive leadership and building relationships with KOLs and investigators...Remote work
- ...Head of Department for Sculpture in New York. You will lead the global Sculpture team, drive consignments, and shape sales strategy... ...proven record in the international sculpture market, with strong leadership, negotiation, and client relationship skills. #J-18808-Ljbffr...Worldwide
- ...The Evangelical Alliance Mission | TEAM is seeking a Director of Learning & Development to lead global people development initiatives from a fully remote... ...coaching, and cross-functional collaboration to drive leadership effectiveness and organizational change. In this...Remote work
- ...the organization. You will translate our story, evidence, and leadership voices into world-class communications, ensuring timely delivery... ..., and guide in-country staff and a network of writers to raise the organization's profile globally. #J-18808-Ljbffr Healthy Learners
$235k - $280k
...Job Title: Senior Director, Global Regulatory Affairs Reports to (Title): VP, Hengrui USA Location... ...lifecycle. The role will play a key leadership role in several upcoming NDA, BLA, and... ...nonclinical, clinical pharmacology, and CMC, ensuring integrated regulatory...Remote workMonday to Friday$157.5k - $210k
...clinical breakthroughs, and bring therapies to market faster. A... ....About the Team:The Senior Director, Global Compliance & Strategy sets... ...the strategic direction for regulatory affairs and quality management... ...partners with executive leadership to shape how compliance informs...Work at officeRemote workFlexible hoursShift work- ...We represent a global P+C carrier looking to hire a Global Compliance Director based in New York City. The role is responsible... ...Insurance & Investment Regulatory Compliance Data Protection,... ...Engagement Global Compliance Leadership Qualifications Experience...Full time
- ...Medidata Solutions seeks a Senior Director, Global Compliance & Strategy to shape regulatory strategy across US and EU for our life sciences platform. You will partner with product, engineering and executive leadership to translate evolving regulatory requirements into...
- ...IQVIA seeks a Director, Managed Access Regulatory Strategy to design regulatory approaches for Expanded Access... ...access to investigational therapies. You will translate client needs... ...helping build new managed access offerings and thought leadership. #J-18808-Ljbffr
- ...JW Michaels & Co. is seeking an Associate Director or Director to join its Global Compliance team in New York. The role reports to the Global Chief... ...Officer and focuses on identifying, assessing and managing regulatory risk across jurisdictions and business lines. You will...
$135k - $180k
...Overview The Manager/Senior Manager of Global Regulatory Affairs Oncology is a member of the Global Regulatory... ...is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved...For contractorsWork at officeLocal areaRemote work$190k - $225k
...Qualifications TEAM OVERVIEW The Global Regulatory Implementation and Transformation team... ...regulators, and partners closely with Business leadership, Technology, Data, Compliance, and Legal. ABOUT THE ROLE The Delivery Director is a senior execution role responsible...Local areaWork from homeFlexible hoursShift work- Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of regulatory CMC documentation, including BLA submissions. You will drive the strategy with Regulatory Affairs and SMEs, delivering rigorous, regulator...
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