Senior Director, Regulatory CMC Strategy — Biotech
Marea Therapeutics, Inc.
Marea Therapeutics, Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for US and global manufacturing programs. This role reports to the Executive Director of Regulatory Affairs and requires strong strategic thinking and hands-on execution in a fast-paced biotech environment. The position is full-time with a preference for on-site work in the San Francisco area, collaborating across cross-functional teams to #J-18808-Ljbffr Marea Therapeutics, Inc.
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and interactions with health authorities. This role reports to the Head of CMC Regulatory and is based in South San Francisco,...Senior
- Kardigan, Inc. seeks a Senior Director, CMC Regulatory to lead regulatory activities for late-stage cardiovascular assets. You will define and execute CMC strategies, interact with global health authorities, and ensure timely, compliant submissions across programs. The...Senior
- Marea Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory strategies for manufacturing across the US and global markets. The role reports to the Executive Director of Regulatory Affairs and will own CMC...SeniorWork at office2 days per week
$258k - $320k
...Description Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological... ...gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58%...SeniorWork at officeWorldwideRelocation package- ...member, from interns to senior leaders. Our... ...seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for... ...development of regulatory strategies and submissions... ...of pharmaceutical or biotech industry experience, at...SeniorFull timeWork at office2 days per week
- Marea Therapeutics in South San Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies for manufacturing products in the US and globally. The role reports to the Executive Director, Regulatory Affairs...SeniorFull time
- Marea Therapeutics seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for the manufacturing of our products in the US and globally. The incumbent will oversee Regulatory CMC aspects of product...Senior
$248k - $310k
...to make a real difference, every day. Position Title: Senior Director, CMC Regulatory Department: Regulatory Affairs Reports To : Head of CMC... ...motivated individual who will help define CMC Regulatory strategies and successfully execute them in submissions and health...Senior$280k - $310k
...get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will... ...development and implementation of all regulatory CMC strategies to support market applications, post-marketing CMC commitments...SeniorLocal area- Nurix Therapeutics, Inc. invites an experienced Director/Senior Director of Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. You will develop and execute the global regulatory strategy, guide high-quality submissions, and work with cross...Senior
- Sentibio in South San Francisco seeks a regulatory affairs leader to drive CMC strategies for a complex cell therapy program. You will shape global regulatory CMC plans, coordinate type B/C/D meetings, and ensure alignment with agency expectations across the organization...
- Zai Lab Limited seeks a senior CMC regulatory leader to drive global regulatory strategy for both small molecules and biologics from its South San Francisco office. You will oversee IND/CTA and NDA/BLA submissions, coordinate with health authorities, and guide cross-functional...Work at office
$270k - $295k
...experienced and highly motivated Senior Director of Regulatory Affairs to lead regulatory strategy and execution across our... ...mindset suited to a fast-paced biotech environment. This position reports... ...regulatory meetings. Partner with CMC, Nonclinical, and Clinical teams...SeniorFull time- Kardigan in Princeton, NJ is seeking a Senior Director, Clinical Pharmacology to lead strategies across cardiovascular development and regulatory interactions with FDA and global health authorities. You will drive dose selection, exposure‑response analyses, PK/PD modeling...Senior
- ...Therapeutics in South San Francisco, CA, is seeking an Associate Director, Procurement to lead sourcing, negotiation, and vendor... ...collaborating with cross-functional teams. You will oversee procurement strategy, leverage Coupa/Concur systems, and ensure GAAP/SOX compliance,...Senior
- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate with R&D, Operations and Global Regulatory teams to enable first-pass approvals and ensure compliant content for INDs...
$275k - $280k
...breakthroughs.Position Description:The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and... ...with cross-functional stakeholders and senior leadership and externally with CMOs and...$166k - $195k
...making.Summary:The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the... ...and analytical activities required in biotech/drug/vaccine development, including knowledge... ...to manage changes in processes, strategy, and competitive landscape.Strong team...Senior3 days per week$232k - $274k
Job Summary: Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team... ...points of view Salary Range: Director: $232K - $274K Senior Director:$279K - $331K Location: Brisbane, CA (...SeniorFor contractorsWorldwide- ...Facebook, Instagram, X and YouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the... ...the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the...SeniorLocal area
- ...Therapeutics is seeking an experienced Senior Director, Quality Control to join the Analytical... ...infrastructure, and a team to support programs from CMC development through commercial... ...small-molecule QC expertise, strong regulatory acumen, and a track record managing...Senior
- Maze Therapeutics seeks an Associate Director, CMC Project Management to drive cross‑functional... ...stakeholders to enable milestones and regulatory success, helping bring medicines to... ...governance, dashboards, and communications for senior leadership while supporting IND/IMPD...Senior
$265k - $285k
...comResponsibilities include: Provides regulatory leadership in support... ..., Medical Affairs, CMC, and Quality to... ...global regulatory strategies and submissions,... ...ability to influence senior leadership and cross-functional... ...environment for biotech companies, as well as...Senior$157.59k - $203.94k
...create possible, together.Job DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs - Combination Products and Device is responsible... ...the development and implementation of global regulatory strategy and is accountable for execution of high-quality...SeniorFull timeFor contractorsLocal area$180k - $195k
...every member, from interns to senior leaders. Our environment is... ...The Role Reporting to the Director, Regulatory Affairs, the Senior Manager... ...international development strategies. This is a full-time, South... ...affairs experience in the Biotech/Pharmaceutical industry strongly...SeniorFull timeFor contractorsLocal area3 days per week- ...leading biotechnology company in South San Francisco seeks a Director of Clinical Regulatory to oversee multiple clinical drug candidates and drive... ..., leading project teams, and developing regulatory strategies. An ideal candidate will have at least 10 years of experience...
- ...Associate Director, Regulatory Affairs (Onsite in S.SF - 3X/wk... ...clinical regulatory strategies and regulatory development... ...works closely with senior regulatory leadership... ..., Medical Writing, CMC, and other functions.... ...promotion of women in biotech. We have achieved gender...Full timeWork at officeWorldwide
$210.38k - $272.25k
...possible, together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products and Device... ...and leading global CMC regulatory strategy for complex, high-impact device and combination... ...strategy and decision-making across senior cross-functional stakeholders in...Full timeFor contractorsLocal area- Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials.... ...global submissions. The ideal candidate will have 5+ years in biotech/pharma regulatory affairs and strong cross-functional...SeniorRemote job
- Zipline seeks a Director of Airspace Policy and Regulatory Affairs to shape how autonomous delivery integrates into global airspace. You will define policy strategy, engage with regulators, standards bodies, and industry peers, and translate regulatory changes into practical...
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