Director, Regulatory Affairs
$245k - $285kSentibio
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 will ensure that all CMC regulatory goals are clearly defined and they align with current industry standards and regulatory requirements. This role will also provide significant input on applicable regulatory affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization. This individual must be highly skilled and provide expertise in CMC agency interactions and developing regional regulatory CMC strategies. In addition, the position assists corporate senior management in understanding CMC Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas. Familiarity with GMP Quality, CMC development and exposure to clinical regulatory strategy is highly desired. (***For the potential candidate at VP level direct report possibilities) Develop the CMC regulatory strategies and manage related regulatory activities. Work with the Pharmaceutical Development team to prepare project plans and timelines for pipeline of products, including coordination and oversight of all types of regulatory CMC submissions including type B, C, D meetings. Supervises/manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA, MAAs, etc. Prep and author updates in conjunctions with the cross-functional teams. Advise the global regulatory phase-appropriate compliance of gene and cell therapy pipeline of products including the evaluation of CMC related change controls, the strategic assessment of process and product comparability, their regulatory impact and implementation. Lead the preparation, authoring, review and filing of CMC sections of regulatory submissions with the highest quality and robust interactions with regulatory agencies. Maintain a centralized archive for tracking and monitoring the status of regulatory CMC commitments and agency reporting obligations. Create and issue status reports and other communication to the organization. Provide strategic CMC regulatory support, guidance and expertise, and act as the Regulatory Affairs primary point of contact to cross-functional teams including Pharmaceutical Development, Quality Assurance, Quality Control, contract organizations and consultants. Ensure that all applicable regulatory requirements/options and associated risks are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines. Work across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise. Ensure the regulatory conformance of technical documentation including technical transfer protocols, validation protocols, technical reports, manufacturing and labeling information. Provide guidance and advice on regulatory CMC environments and trends; provide assessment of the impact of new and changing regulations/requirements. Author, review, and maintain regulatory and scientific documents to support business and submission needs. Track and report on Medical Writing and Regulatory Operations projects, timelines, and key milestones to support timely execution. BA/BS in a scientific field of study with 10 years + of relevant experience working in Regulatory in the pharmaceutical/ biotech industry. Strong knowledge, experience and leadership in interpretation of regulations and guidelines related to biologics drug development. Experience in the gene or cell therapyarea is preferred. Proven ability to analyze and organize information logically. In depth understanding and application of industry standards and international regulations and guidelines. Experience in communicating regulatory strategy, submission documents and plans both internally and externally. The ability to coordinate and prioritize multiple projects in a fast-paced, deadline driven start-up environment. Strong collaboration, team work, organizational skills at attention to detail Excellent written and verbal communication skills. Travel 20% Compensation for this role includes base salary, annual target bonus and equity The base salary range for this role is $245,000-285,000. Starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity Significant growth opportunity as the company expands Empathetic, supportive and collaborative colleagues and work environments #J-18808-Ljbffr
$275k - $280k
...medical breakthroughs. Position Description: Calico is seeking a Regulatory Director that will be responsible for, in collaboration with... ...develop effective CMC regulatory strategies Represent Regulatory Affairs on development teams and support development teams in...SuggestedFull time- ...Associate Director, Regulatory Affairs The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory strategies and regulatory development activities for assigned programs across regions. This role works closely with senior...SuggestedWork at office
$120.2k - $223.2k
The PositionCommercial Regulatory Affairs (CORA) is part of the Global Product and Access Legal (GPAL) organization that interprets the needs... ...in the Global Legal Pharma Department.Associate Program Directors of Commercial Medical Legal Regulatory Review Committees (CMLRs...SuggestedFull timeWork experience placementLocal areaWorldwideRelocation package$265k - $285k
...****@*****.*** include: Provides regulatory leadership in support of the development, registration, and... ...with Clinical Development, Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate, and implement global...Suggested$275k - $280k
...longer, healthier, and happier lives! About the Job: The Senior Director of Regulatory CMC will lead the development and execution of global CMC... ..., AND 9+ years focused specifically on CMC Regulatory Affairs. A successful history of contributing to least two major marketing...SuggestedLocal areaRelocationRelocation package3 days per week- ...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...
$210k - $260k
...Director, Regulatory Affairs Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results...Temporary workLocal area- ...s hybrid model requires this role to work in our office three days per week on average. Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices...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...
$232k - $274k
Job Summary: Nurix Therapeutics, Inc. is seeking a Director/ Sr. Director, Regulatory Affairs (Strategy, Oncology - Solid Tumors) to join the Regulatory team. The successful candidate will be a core member of the Regulatory team working in close collaboration with the...For contractorsWorldwide- Position Title: Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier...For contractorsWork at office
$220k - $270k
Senior Director/ Director, CMC Regulatory Affairs ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by overcoming resistance in cancer. ORIC’s clinical stage product candidates include ORIC-944 and enozertinib. ORIC...Currently hiring$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...Temporary workCasual workLocal areaRemote workWorldwideFlexible hours$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory direction for first-in-class cell therapies...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$210.38k - $272.25k
...developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionThe Director, CMC Regulatory Affairs - Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for complex,...Full timeFor contractorsLocal area$302.01k - $390.83k
...together.Job DescriptionPOSITION OVERVIEW:The Executive Director, Head of Precision Medicine Regulatory is responsible for defining and leading enterprise-... ...closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with...Full timeFor contractorsWork at officeLocal areaFlexible hours- ORIC Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You will collaborate with regulatory, quality, clinical, and manufacturing teams to develop regulatory strategies...
$263.88k - $307.86k
## Senior Director, Regulatory Affairs REMS ProgramApplylocations: South San Francisco, Californiatime type: Full timeposted on: Posted 2 Days Agojob requisition id: R482Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years...For contractors$188k - $215k
...Senior Manager/Associate Director, Regulatory SciencesMavericks WantedIn 2015, we pioneered a "moneyball for biotech" approach, pooling projects... ..., Drug Product, and Analytical Development) and Regulatory Affairs to design and implement control strategies in alignment with...Full timeWork at officeLocal areaRemote workFlexible hours$205k - $225k
...Associate Director, Regulatory Affairs Advertising and Promotion Foster City Mission Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become...Work at officeLocal area$138.3k - $256.8k
...integrity and creativity while boldly pursuing answers to the world’s most complex health challenges and transforming society. Public Affairs & Access (PAA) is a multi-disciplinary organization that includes Corporate Communications; Policy, Evidence & Access Strategy;...Contract workWork experience placementWork at officeLocal areaRelocation package3 days per week- ...general, automated, and reporting controls, technology processes, data flows, or system interfaces. Supporting external audits, regulatory exams, or compliance reviews. Proven ability to manage evidence requests, remediation, corrective‑action plans, and audit timelines...
- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases Industry Biotechnology Type Privately Held, VC-backed Founded 2018 Employees 51-200 Funding...
$280k - $310k
...other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSTION SUMMARYThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the...Local area$275k - $280k
...pipeline, 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...- ...immense opportunity to leverage our Pod platform to detect medical conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a business around this opportunity. This role will provide leadership for risk...Night shift
$244k - $305k
...Revolution Medicines is seeking a seasoned professional for regulatory management in oncology. The ideal candidate will have over 12 years... .../biotech industry and a minimum of 8 years in Regulatory Affairs. Responsibilities include directing regulatory strategy for late...- ...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...
$160k - $185k
...Job Description We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical development of oncology products at ORIC. In this role, you will collaborate closely with colleagues across regulatory operations, quality, CMC...Odd jobH1bWork at office- ...A cutting-edge infrastructure company in San Francisco is seeking a detail-oriented regulatory professional to enhance its AI platform for energy and critical infrastructure. Candidates should have experience in permitting and environmental compliance, alongside strong...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Regulatory Affairs. Be the first to apply!
- 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

