Regulatory Affairs Manager
Erasca, Inc.
Erasca is seeking a Sr Manager/Assoc Director, CMC Regulatory Affairs to lead regulatory activities for IND/CTA development and ongoing trials. The role involves preparing CMC documents, ensuring regulatory compliance, and coordinating global submissions. The ideal candidate will have 5+ years in biotech/pharma regulatory affairs and strong cross-functional collaboration skills. The position offers salary with bonus potential and equity, and may be based in San Diego or South San Francisco, with #J-18808-Ljbffr
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Manager in South San Francisco, CA vacancy
$175k - $205k
...Sr Manager/Assoc Director, CMC Regulatory AffairsSan Diego, CA, South San Francisco, CA or remoteErasca is a clinical-stage precision oncology company... ...:Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory...SuggestedTemporary workCasual workLocal areaWorldwideFlexible hoursErasca, Inc.
South San Francisco, CA1 day ago$334.99k - $413.81k
...of the Roche group. You will be responsible for architecting, managing and overseeing the governance and strategic framework for compliance... ...guidelines that are compliant with state and federal laws and regulatory requirements. Oversee the team accountable for policy,...SuggestedFull timeFixed term contractWork at officeLocal areaRemote workRelocation package$243k - $299k
...organization’s commitment to ethical business practices, and regulatory compliance as we prepare for our first potential commercial launch... ...skills with experience in auditing, monitoring, and risk management. Excellent communication, analytical, and interpersonal skills...SuggestedWork experience placementWork at officeLocal areaFlexible hours3 days per weekDenali Therapeutics
South San Francisco, CA1 day ago$275k - $280k
...Position Description: Calico is seeking a Regulatory Director that will be responsible for,... ...regulatory strategies Represent Regulatory Affairs on development teams and support... ...MAA, etc.)Direct experience authoring and managing (or oversight of others) substantial regulatory...SuggestedFull time$120.2k - $223.2k
The PositionCommercial Regulatory Affairs (CORA) is part of the Global Product and Access Legal (GPAL) organization that interprets the needs... ...CMLRs with oversight from CORA Program Directors and their managers. They are experienced individual contributors expected to...SuggestedFull timeWork experience placementLocal areaWorldwideRelocation package$138.3k - $256.8k
...most complex health challenges and transforming society. Public Affairs & Access (PAA) is a multi-disciplinary organization that... ...Communications; Policy, Evidence & Access Strategy; Channel & Contract Management; External Affairs; Patient Experience; and Strategy and...Contract workWork experience placementWork at officeLocal areaRelocation package3 days per weekGenentech
South San Francisco, CA3 days ago- ...documentation, process walkthroughs, evidence collection, timeline management, and remediation. Assess IT general, automated, reporting, and... ...data flows, or system interfaces. Supporting external audits, regulatory exams, or compliance reviews. Proven ability to manage...
Jobtailor
San Bruno, CA3 days ago $265k - $285k
...staffingfuture.comResponsibilities include: Provides regulatory leadership in support of the development, registration, and life-cycle management of products by collaborating cross-... ...Development, Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate,...$198k - $257k
...Description Primary Function: The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory... .... Regulatory Submissions: Plan, prepare, and manage Investigational New Drug (IND) applications and other pre‑ or...Full timeWork at officeWorldwideRelocation packageZai Lab (US) LLC
South San Francisco, CA24 days ago$275k - $280k
...together create an inspiring and exciting place to catalyze and enable medical 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...- ...over 20 years and is currently expanding its pharmaceutical division. As part of this growth, the organization is seeking a Regulatory Affairs Manager CMC to join their Regulatory team in San Francisco. This is an exciting opportunity to play a hands-on role in regulatory...
Barrington James
San Francisco, CA2 days ago $80 - $85 per hour
...from ACL Digital Job title: PRC Submission Management Lead Location: Foster City, CA Duration:... ...expertise in the Medical, Legal, and Regulatory (MLR) review and approval process, with... ...experience in US Commercial Regulatory Affairs, specifically within PRC/MLR review operations...Contract workACL Digital
Foster, CA2 days ago$245k - $285k
...The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell therapy product on a global basis. The successful candidate...Contract workSentibio
South San Francisco, CA3 days ago$275k - $280k
...! About the Job: The Senior Director of Regulatory CMC will lead the development and execution... ...and all relevant major markets Actively manage the lifecycle of the Common Technical... ...focused specifically on CMC Regulatory Affairs. A successful history of contributing to...Local areaRelocationRelocation package3 days per weekMeet Life Sciences
South San Francisco, CA1 day ago- ...Are you a seasoned Regulatory Affairs professional ready to make a significant impact on human health? We are seeking a strategic and driven Director of Regulatory Affairs to join a pioneering research and development company focused on extending healthy lifespan. This...
Enigma Search
South San Francisco, CA17 hours ago - ...Radical Ventures and NVIDIA. Learn more about our vision, team, and backers at About the Role We’re looking for a Policy & Regulatory Affairs Manager to help shape and execute our policy and regulatory strategy at a critical moment of growth. As demand accelerates and...Work from homeFlexible hours2 days per week
- Kardigan is looking for an Associate Director, Regulatory Strategy to support regulatory... ...will collaborate cross-functionally and manage submission timelines while reporting to... ...least 6 years of experience in regulatory affairs, particularly within biotech or pharmaceuticals...
- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will... ...INDs/CTAs and variations. You will also guide agency meetings, manage change controls, and mentor team members. The role requires...
- Enigma Search is seeking a Project Manager, Regulatory Affairs to bring structure, visibility, and execution excellence to our growing regulatory team in the biopharmaceutical space. You will manage regulatory planning, timelines, and cross‑functional coordination across...
- ...per week on average. Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing... ..., risk identification, and proactive planning Develop and manage a clinical trial public disclosure tracker and lead periodic...Work at officeLocal areaRemote workNight shift3 days per week
- Enigma Search is seeking a seasoned Director of Regulatory Affairs to shape regulatory strategy for innovative programs. You will lead global submissions, interact with health authorities, and partner with executive leadership to align regulatory plans with corporate aims...
- ...Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation... ...of Module 2/3, IMPD, and post-submission activities, manage timelines, and mentor a regulatory team in a fast-paced, collaborative...
$302.01k - $390.83k
...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 strategies, including risk...Full timeFor contractorsLocal area$263.88k - $307.86k
Cytokinetics is seeking a Senior Director for Regulatory Affairs in South San Francisco. This role involves leading regulatory strategies related... ...and Mitigation Strategies (REMS), ensuring compliance, and managing cross-functional teams. The ideal candidate has over 10...- Nurix Therapeutics, Inc. is seeking a Sr. Director, Head of Regulatory & Medical Writing to lead the regulatory writing group and guide the preparation of high-quality regulatory documents for clinical trials and submissions. You will collaborate with Clinical Science,...
- Position Title: Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics is a clinical stage biopharmaceutical... ...support of early development, registration and life cycle management activities. This position works cross-functionally with...For contractorsWork at office
- ...Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (... ...to the Executive Director of Regulatory Affairs and will own CMC submissions and... .... The candidate will lead CMC strategy, manage regulatory interactions, and build a high...Work at office2 days per week
$232k - $274k
...Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory... ...and interactions in support of registration and life cycle management activities. This position works cross-functionally with regulatory...For contractorsWorldwide- ...San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (... ...reports to the Executive Director, Regulatory Affairs and collaborates across Tech Ops to... .../IND and BLA/MAA filings for biologics, manage the CMC document control system, and...
- Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies, ensuring compliance with health authority guidelines. The role requires collaboration with various teams, overseeing regulatory submissions...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Manager. Be the first to apply!
Related searches
- regulatory cmc manager South San Francisco, CA
- regulatory manager South San Francisco, CA
- director global regulatory affairs South San Francisco, CA
- manager regulatory affairs South San Francisco, CA
- head compliance South San Francisco, CA
- compliance manager South San Francisco, CA
- compliance director South San Francisco, CA
- senior director regulatory affairs South San Francisco, CA
- regulatory affairs director South San Francisco, CA
- healthcare compliance manager South San Francisco, CA