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
$175k - $205k
...Sr Manager/Assoc Director, CMC Regulatory Affairs San Diego, CA, South San Francisco, CA or remote Erascais a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs...SuggestedTemporary workCasual workLocal areaRemote workWorldwideFlexible hours$160k - $185k
...Diego, California. Job Description We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical... ...internal and CRO teams to ensure optimal execution. Develop, manage and track regulatory submission timelines. Collaborate cross-...SuggestedOdd jobH1bWork at office$200.7k - $234.15k
## Associate Director, Regulatory AffairsApplyremote type: Hybridlocations: South San Francisco... ...to the Executive Director, Regulatory Affairs, the Associate Director, Regulatory... ...authority interactions* Proven ability to manage multiple priorities and work effectively...Suggested$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 week$334.99k - $413.81k
...program for Genentech. You will be responsible for architecting, managing and overseeing the governance and strategic framework for... ...guidelines that are compliant with state and federal laws and regulatory requirements. Oversee the team accountable for policy, training...SuggestedFixed term contractWork at officeLocal areaRemote workRelocation package- ...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...
$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 work$135k - $150k
...Jade Biosciences is looking for a Regulatory Affairs Manager to support the execution of regulatory strategies in a remote position. Responsibilities include managing submissions and ensuring compliance with global regulations. The ideal candidate will have 5-8+ years...Remote work- ...in Santa Monica, CA is seeking a Commercial Labeling Project Management Contractor to oversee end-to-end labeling workflows, coordinate... ...operations. The role requires 3–5+ years in pharmaceutical labeling or regulatory operations, familiarity with Veeva Vault, Acrobat, and...For contractors
$225k - $262.5k
...Director, Regulatory Affairs Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering... ...business partners to achieve program regulatory goals Manages coordination, preparation, and timely submission of...For contractors- ...Director, Regulatory Affairs Position Title: Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics... ...in support of early development, registration and life cycle management activities. This position works cross-functionally with regulatory...For contractorsWork at office
- ...Director, Regulatory Affairs South San Francisco, California, United States Director, Regulatory Affairs 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...
$275k - $280k
...Description : Calico is seeking a Regulatory Director that will be responsible for,... ...strategies Represent Regulatory Affairs on development teams and support development... ....) Direct experience authoring and managing (or oversight of others) substantial...Full time- ...biopharmaceutical company in South San Francisco, is seeking a Director of Regulatory Affairs CMC to lead global CMC regulatory strategies across clinical... ...to ensure timely, compliant submissions and robust change management, reporting to the VP Regulatory Affairs. #J-18808-Ljbffr...
$210.38k - $272.25k
...critical connector across Legal, Tax, and Finance, ensuring regulatory compliance, financial integrity, and optimized trade execution... ...valuation, intercompany pricing, and financial reporting Risk Management & Controls * Lead global trade compliance risk assessments...Full timeContract workFor contractorsLocal area- ...is incredibly easy for anyone to jump in and use– it boosts our efficiency because we don’t have to train interviewers and hiring managers to use it. Professional Plastics eliminates 100s of hours of work in 3 months. We were doing everything manually, trying to stay on...
- ...information at Job Purpose / Summary We seek an experienced Regulatory professional to manage regulatory activities associated with pipeline and late... ...and CMOs. This position reports into the SVP Regulatory Affairs and Quality Assurance. The candidate must be able to...Remote work
- A growing ultrasound medical device company is seeking a Regulatory Program Manager to support the development and regulatory advancement of next... ...milestones. This person will work closely with Regulatory Affairs, Quality, Engineering, Clinical, Operations, and Product...
$159k
...Operations / Strategy Job Level: Senior Manager Business Unit: Strategy & Growth... ...enterprise policies and external/internal regulatory requirements. It partners cross-functionally... ..., analytical, communications or public affairs related position Electric industry...Contract workWork experience placementWork at officeFlexible hours2 days per week3 days per week$275k - $280k
...Position Description : The Director of Regulatory CMC will lead the development and... ...for US, EU, and other major markets ~ Manage the lifecycle of the Common Technical Document... ...focused specifically on CMC Regulatory Affairs ~ Successful track record of...£100 per hour
...in 2018, Copper has been building the standard for institutional digital asset infrastructure with a focus on custody, collateral management, and prime services.Led by Amar Kuchinad, Copper’s Global CEO, the firm provides a comprehensive suite of custody, trading and...Work from homeFlexible hours$122.54k - $128.99k
...Job Summary The Associate Director of Compliance ensures regulatory and compliance requirements are met for all properties owned and/or managed by Chinatown Community Development Center. The Associate Director ensures prompt contract renewals with various agencies (HUD...Full timeContract workLocal areaWork from homeMonday to Friday- ...Officer (CCO) to join its team. The CCO will be a key strategic leader, responsible for overseeing all credit and portfolio risk management functions. This includes maintaining a high-quality loan portfolio, minimizing credit losses, and ensuring sound credit risk management...
$340k - $370k
Description Position Summary: The VP of Regulatory and Head of Regulatory Affairs will shape and execute regulatory strategies and lead and manage submissions to support clinical development and regulatory compliance for Sagimet. This role will serve as the primary...Full time- ...Department across the portfolio. The role requires extensive LIHTC, HUD, and TCAC knowledge, with oversight of audits, inspections, and regulatory reporting. You will develop compliance strategies, mentor staff, and liaise with regulatory agencies. The ideal candidate has...
- ...candidate will be responsible for leading and maintaining the firm's regulatory compliance program, serving as the primary liaison for... ...with federal and state regulatory requirements, as well as the management of tax reporting and withholding compliance. The Head of Compliance...
- ...Collective, among others. We are looking to hire a Head of Regulatory Affairs for our Clinical/Regulations Team. What You'll Do:... ...Lead preparation and response for FDA inspections Write and manage Q-Sub (pre-submission) packages Cross-functional execution...
$302.01k - $390.83k
...possible, together. Job Description JOB DESCRIPTION Lead 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...For contractorsLocal area- ...Head of Regulatory Affairs About the Company Small scientifically driven biotech advancing a novel therapy for rare disease and expanding... ...be directly involved in the regulatory process, rather than managing a large team. The position is pivotal in the expansion of...
- ...overseeing the implementation of the U.S. compliance regime, managing the compliance technology suite, maintaining annual corporate... ..., and ensuring that all products and services comply with the regulatory landscape. Applicants for the Chief Compliance Officer position...
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