Director, Global Regulatory Submissions (Hybrid)
Rigel
Rigel Pharmaceuticals, Inc. in South San Francisco seeks a Director, Regulatory Affairs to oversee regional/global regulatory submissions, ensuring strategies align with therapeutic area direction and corporate objectives. You will lead SOP development, regulatory operations, and inspection readiness while coordinating with outside contractors and internal teams. The role reports to the Vice President of Regulatory Affairs and requires strong project management, communication, and multi-project #J-18808-Ljbffr Rigel Pharmaceuticals, Inc.
$265k - $285k
...staffingfuture.comResponsibilities include: Provides regulatory leadership in support of the development, registration... ..., and Quality to develop, coordinate, and implement global regulatory strategies and submissions, including CTAs, for new and ongoing clinical studiesLead...Suggested- Enigma Search in the United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small molecules and monoclonal antibodies... ...with CMC, Quality, and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD, ensure regulatory...Suggested
- ...Pharmaceuticals, Inc. is seeking a senior Regulatory Writing lead reporting to the Vice... ...oversees the technical writing for regional/global submissions, aligning with therapeutic area... ...headquarters, with a structured onsite/hybrid schedule for residents in the area. #J...Suggested
$185k - $205k
...and provide access to a $15 billion global market opportunity. Our follow-on product... ...beyond. About the Role >>> Associate Director, Global Regulatory Affairs, Compliance and Project... ...and guidance documents for regulatory submissions and regulatory operational activities...SuggestedWork at officeFlexible hours$15 per hour
...Associate Director, Global Regulatory Affairs Compliance Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming... ...themanagementand complianceof high-quality regulatory submissions—including INDs, NDAs, health authority meeting materials,...SuggestedWork at officeFlexible hours2 days per week$225k - $262.5k
...Director, Regulatory AffairsSkip to main content# CareersDirector, Regulatory... ...development and execution of global regulatory strategies and... ...coordination, preparation, and timely submission of regulatory documents,... ...multiple priorities #LI-HYBRID**Pay Range:**In the U.S., the...For contractors$200k - $235k
...to the Vice President of Regulatory Affairs-, this position is... ...oversight of regional and/or global regulatory submissions and ensures strategies are... ...corporate objectives. The Director, Regulatory Affairs will... ...Employees designated as onsite or hybrid are expected to be onsite...For contractorsRemote workFlexible hours$230k - $250k
...and provide access to a $15 billion global market opportunity. Our follow-on product... ...what’s beyond. About the Role As the Director, Global Regulatory Strategy Lead - Regulatory Affairs... ...and lead the development of regulatory submissions (INDs, CTx, briefing documents, IB,...Work at officeFlexible hours2 days per week- ...lives of patients for generations to come.Regulatory Submission Management (RSM) acts as a partner for... ...execution of the portfolio, to ensure global Regulatory submissions are scalable,... ...faster, together. As an Associate Director, RSM, you will have a primary focus on...Full timeFor contractorsLocal areaRelocationFlexible hours
- ...Clinical Trial Manager / Sr. CTM to drive global oncology trials from protocol through... ...while maintaining high quality. Strong regulatory knowledge and TMF stewardship are required... ...Preferred onsite two days weekly as part of a hybrid model in South San Francisco, CA....
$240k - $260k
...done, and have fun, seriously. Position Summary The Director, Global Regulatory Affairs Advertising and Promotion provides strategic and... ...regulatory guidance for the preparation, review, approval, and submission of advertising and promotional materials.. The...Work at officeLocal area$230k - $270k
...Therapeutics is seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory Affairs and Clinical Quality... ...Authority requirements and regulatory submissions are on time and high quality. The position is a hybrid role located in South San Francisco and...Contract workInternshipLocal areaRemote work2 days per week$185k - $250k
...financed by top-tier global life sciences investors... ....Position Summary:The Director, Global GCP QA is responsible... ...across global regulatory requirements (FDA, EMA... ...clinical and regulatory submission (e.g. IND/NDA)... ...or ONSITE (if onsite, hybrid model).Structure Therapeutics...Contract workRemote work$275k - $355k
...Reporting to the Chief Regulatory Affairs Officer, the Executive Director or VP, Regulatory Affairs will... ...area and develop and execute global regulatory strategies and submissions from pre-IND through... ...that this position can be hybrid in San Diego, CA or South San...Temporary workCasual workLocal areaRemote workWorldwideFlexible hours- ...Responsibilities Direct planning and execution of highly complex global regulatory submissions and programs Partner with Regulatory Affairs Liaisons to develop and maintain global filing plans with regulatory milestones Oversee submission lifecycle execution and...
- ...and a member of myGwork – the largest global platform for the LGBTQ+ business community... ...patients for generations to come. Regulatory Submission Management (RSM) acts as a partner for... ...faster, together. As an Associate Director, RSM, you will have a primary focus on...Full timeLocal areaRelocationFlexible hours
$141.5k - $268.5k
...Associate Director, Regulatory Affairs Advertising & Promotion - Oncology Full-time Salary Min... ...141500 Salary Max: 268500 Workday Global Grade: 20 Compensation: USD 141,500 -... ...leads initiatives This role will work a hybrid work schedule (3 days in office, 2 days...Full timeWork at officeRemote work$180k - $241k
...has secured partnerships with leading global biopharmaceutical companies, generating... ...Primary Function: The Associate Director, Regulatory Affairs supports the development and execution... ..., execute regulatory plans, prepare submissions, and support health authority...Remote workWorldwideRelocation package$141.5k - $268.5k
...Associate Director, Regulatory Affairs US Advertising and Promotion - Immunology Full-time Salary... ...Salary Max: 268500 Workday Global Grade: 20 Compensation: USD 141,500 -... ...leads initiatives This role will work a hybrid work schedule (3 days in office, 2 days...Full timeWork at officeLocal areaRemote work- ...All Jobs Director / Senior Director / Executive Director, Regulatory Affairs Director / Senior Director / Executive Director... ...leads regulatory strategy and submission execution for one or more... ...someone with deep knowledge of global regulatory requirements, a track...Full timeRemote work
- ...for employment. Position: Director, Regulatory Writing Location: Remote Job... ...: South San Francisco / Hybrid/ Remote About the Company Neurona... ...and toward regulatory submission, we are seeking an experienced... ..., clinical development, and global regulatory requirements. Experience...Remote work
$275k - $280k
...Position Description: Calico is seeking a Regulatory Director that will be responsible for, in... ...risk mitigationLead interactions with global health agencies to inform global regulatory... ...enable the compilation, review, and submission of regulatory applications and...Full time$324.62k - $420.09k
...increasingly informing regulatory decisions across... ...EpiRWE), the Executive Director, Regulatory RWE Strategy... ...Heads and their teams, Global Regulatory Affairs, Biostatistics... ...programs, studies, submissions, and relationships... ..., external controls, hybrid designs or novel...Full timeFor contractorsLocal areaImmediate startShift work- ...Medicines360.org Position Title: Director, Regulatory Affairs Reports To: Head... ...Location: San Francisco – Hybrid POSITION SUMMARY: The... ...developing and executing global regulatory strategies for a... ...responsible for the development, submission, and maintenance of...Full timeWork at officeLocal areaWorldwide
- Vera Therapeutics, Inc. is seeking a Manager of Regulatory Operations to lead publishing and formatting of regulatory submissions, ensuring compliance with global requirements. The role supports cross-functional teams and uses Veeva Vault RIM for submissions management...
$146k - $182.5k
...San Francisco, CA, or Princeton, NJ. Acadia's hybrid model requires this role to work in our... ...on average. Position Summary The Associate Director, Regulatory Operations provides leadership for global regulatory submissions, regulatory information management, document...For contractorsWork at officeLocal areaRemote workNight shift3 days per week- ...Senior Manager/Associate Director position leading regulatory strategy for hematology-oncology programs at... ...Responsible for building and executing global regulatory strategies, managing... ...ensure compliance Prepare regulatory submissions including INDs, NDAs, DSURs, and...
$269k - $350k
...patients. This role leads clinical regulatory strategy across Denali's... ...scientifically rigorous, globally coherent, and aligned with the... ...than program-level or submission-level tactics. The role requires... ...Global Regulatory Leads (Senior Directors and Directors), setting the...Local areaShift work$140k - $187.25k
About This RoleThe Sr. Manager, Global Regulatory Affairs (GRA) supports the regulatory strategy and execution for assigned programs, working... ...to the development and implementation of regulatory submissions across multiple regions, ensuring alignment with global regulatory...Full timeTemporary workLocal area- Senior Manager / Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) Nurix Therapeutics... ...for helping build and execute on global regulatory strategy, objectives,... ...maintenance of regulatory application submissions Conduct research and stay up-to-date...For contractors
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