Regulatory Affairs Manager, CMC - Onsite 3 Days
Adicet Bio
Adicet Bio, Inc. is a clinical stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategies and submissions in early to late-stage development, supporting additional clinical and nonclinical regulatory activities. The role reports to the Regulatory group and requires strong interaction with cross-functional teams, external partners, and regulatory authorities, with #J-18808-Ljbffr Adicet Bio
- ...therapies for autoimmune diseases and cancer. The Manager, Regulatory Affairs will lead global CMC regulatory strategy and submissions to... ...clinical and product development. The role requires onsite work with a minimum three days per week in the office; the candidate will...SuggestedWork at office3 days per week
$166k - $195k
...decision making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to... ...requirements, and eCTD structure (Module 3 CMC content). Direct experience... ...changes to company policy): Hybrid (3 days per week onsite)Compensation:The compensation package...Suggested3 days per week- ...new member of our Regulatory team who will own the... ..., and Controls (CMC) regulatory work. As... ...of the Regulatory Affairs team, you will work... ...This position is an onsite role based in Redwood... ...workstreams, manage multiple priorities... ...development (e.g., Phase 3) and...Suggested
- Adicet Bio, Inc. seeks a Manager, Regulatory Affairs to lead global CMC regulatory strategies for its cell therapy programs. You will manage submissions and... ...ability to drive timelines in a fast-paced setting. Onsite presence is required for collaboration across teams....Suggested
- Retro is seeking an experienced Regulatory professional to own the strategy and operations for CMC regulatory work across our aging biology programs. This onsite role in Redwood City reports to the Regulatory Affairs leader and will build out global CMC capabilities for...Suggested
- ...A biopharmaceutical company in Redwood City is seeking an Executive Director of Regulatory Affairs CMC to lead the regulatory strategy for drug products. The ideal candidate will have 15 years of regulatory CMC experience and a successful track record in preparing BLAs...
$180k - $210.5k
...develops and executes multi-product global regulatory CMC strategies for investigational products... ...filing of regulatory CMC submissions. Manages interactions with Health Authorities... ...Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices...- ...Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic... ...a monoclonal antibody or therapeutic protein. 5+ years of management experience preferred. The salary is competitive and commensurate...
$153k - $178k
...oriented Lab Compliance Manager to join our Global... ...Analytical support Vaxcyte's CMC programs by performing... ...activities that enable regulatory filings. This role will... ...Specialist, providing day-to-day oversight of sample... ...to company policy): Onsite (minimum of 5 days per...Work experience placement$130k - $179k
...Manager, Regulatory Affairs Redwood City, CA JOIN US! Adicet Bio, Inc. is a clinical stage... ...responsible for managing the global CMC regulatory implementation of assigned... ..., employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory...Full timeTemporary workWork at officeFlexible hours3 days per week$302.01k - $390.83k
...aspirations. Join Gilead and help create possible, together.Job DescriptionJOB DESCRIPTIONLead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives.Lead global CMC regulatory...Full timeFor contractorsLocal area$211k - $264k
...Opportunity:The Director of Regulatory Affairs (US Filing Lead) is... ...at RevMed. They will manage end-to-end execution of... ...Clinical, Biostatistics, CMC, Quality, Translational... ...of large, global Phase 3 registrational studies... ...for candidates working onsite at our headquarters in...Full timeWork experience placementLocal area$250k - $300k
Menlo Park, CARegulatory Affairs - Regulatory Affairs /Regular, Full-Time Employee... ...operations and lifecycle management, while also maintaining... ...indications, global expansion, CMC Regulatory and other significant... ...function and team, with day-to-day decision-making authority...Full timeLocal areaImmediate startRemote work- ...raised a $126M Series C at a $3.5B valuation, led by Avenir... ...in our Menlo Park office five days a week, unless otherwise... ...About the Role The Head of Regulatory Affairs is responsible for leading and... ...sections, coordinating data inputs, managing timelines, and ensuring high-...Work at office
$129.5k - $175k
...leader in Intelligent Content Management. Our platform enables organizations... ...processes every single day: contracts, invoices, employee... ...across multiple frameworks and regulatory standards, including but not limited... ...assigned office a minimum of 3 days per week.Your Recruiter...Live inWork at officeShift work3 days per week$300k - $350k
...are compliant with global regulatory requirements and Vaxcyte quality... ...continuity, and effective management of quality risk, with... ...across Technical Operations, CMC, Regulatory, and Supply Chain... ...): Hybrid (minimum of 2-3 days per week onsite)Compensation:The compensation...Contract workRelocationRelocation package2 days per week3 days per week$186k - $233k
...Opportunity:The Associate Director, Global Regulatory Affairs Project Management is an integral part of the global... ..., Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and... ...time position for candidates working onsite at our headquarters in Redwood City,...Full timeWork at officeLocal area$157.59k - $203.94k
...empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and Device is responsible for supporting CMC regulatory activities for development or lifecycle...Full timeFor contractorsLocal area$280k - $310k
...and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide... ...topics, and effectively oversees change controlsBuilds and manages relationships through active partnering with key internal and...Local area$160k - $190k
...challenging environment in which to thrive.We are currently seeking a Senior Regulatory Affairs Manager to join our team. This is a hybrid position based in the Mountain View, CA office 2-3 days a week. This individual will be responsible for regulatory support for new...Work at office2 days per week3 days per week$183k - $194k
...executes multi-product global regulatory CMC strategies for... ...regulatory CMC submissions. Manages interactions with Health Authorities... ...Functions:Represent Regulatory Affairs in various internal cross-functional... ...plus.Experience with module 3.2S and 3.2P.Computer software...RelocationRelocation package$80 - $85 per hour
4 days ago Be among the first 25 applicants This range... ...title: PRC Submission Management Lead Location: Foster... ...the Medical, Legal, and Regulatory (MLR) review and... ...Commercial Regulatory Affairs, specifically within PRC... ...Experience: 6-8 years Top 3 Required Skill Sets: a...Contract work$244k - $305k
...Director, Molecule Global Regulatory Lead will develop and... ...and lifecycle management. This leader will shape... ...Development, Biometrics, and CMC to deliver high-... ...+ years of regulatory affairs experience within the... ...for candidates working onsite at our headquarters in...Full timeLocal area- ...ICH, cGMP, and global regulatory expectations. Key Responsibilities... ..., monitoring, and management of development,... ...activities. Author and support CMC stability sections for... ...there. This is an onsite role and requires the... ...applicant to be in the office 3 days a week. TSP Talent...Contract workWork at officeRelocation3 days per week
$175k - $225k
...Director, Quality Assurance - CMC Operations... ...or older and is in Phase 3 development for psoriatic... ...responsible for leading and managing QA activities, oversight... ...and guidance regarding regulatory requirements, and GMP guidelines... ...office in Newark, CA 4 days a week....Full timeTemporary workWork at officeFlexible hours$171k - $214k
...teachers and students rely on every day, your contributions help turn... ...Principal IT Technical Program Manager to lead large-scale, strategic IT... ...position requiring you to be onsite for at least 60% of the working month, approximately 3 days a week, with specific in-office...Work at officeRelocation package3 days per week$85 - $100 per hour
...actively looking for Compliance Manager, in Mountain View, CA area!... ...a hybrid role requiring 2–3 days onsite per week. Note : This... ...internal audit leadership, regulatory compliance activities, inspection... ...Partner with Regulatory Affairs, Quality, Commercial, and...Weekly payContract workLocal area2 days per week3 days per week$194k - $199k
...Therapeutics, Inc. is seeking an experienced Associate Director of Regulatory Affairs, CMC to coordinate global regulatory filings. This role requires... ...of FDA and EU regulations. The position focuses on managing CMC regulatory aspects and preparing submissions. The salary...Work at office- ...interest, third-party risk management, anti-bribery and... ...Support Quality and Regulatory departments with compliance... ..., Marketing, Medical Affairs, Market Access, and... ...coordinate, and track day-to-day compliance activities... ...candidates working onsite at our headquarters in...Full timeWork at officeLocal areaRemote workRelocation
- ...Title: Regulatory Affairs Specialist 4 Location: Sunnyvale, CA - Hybrid (3 days per week onsite) Duration: 6 months Description: Primary Function of Position... ...Regulatory working knowledge of product lifecycle management, design controls, risk management,...3 days per week
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