Director of Regulatory Affairs
Precision Point
Director, Regulatory Affairs Strategy
About the Rol
eWe are seeking a Director of Regulatory Affairs Strategy to lead the development and execution of global regulatory strategies across our clinical pipeline. This individual will serve as the primary regulatory strategist for one or more development programs, partnering closely with cross functional teams to drive programs from IND through approval. The role offers significant visibility with senior leadership and the opportunity to shape regulatory direction for novel therapeutics
.
Key Responsibiliti
- esDevelop and own global regulatory strategies for assigned programs, including US, EU, and key international marke
- tsServe as the regulatory lead on cross functional program teams, providing strategic guidance on study design, endpoints, and development pathwa
- ysLead preparation and execution of health authority interactions, including pre IND, End of Phase 2, Type B/C meetings, and scientific advice procedur
- esDirect the planning, authoring strategy, and submission of INDs, CTAs, BLAs, NDAs, and MAAs in collaboration with regulatory operations and external partne
- rsEvaluate and advise on expedited pathways such as Breakthrough Therapy, Fast Track, RMAT, PRIME, and Orphan Drug designatio
- nsMonitor the evolving regulatory landscape, competitor precedents, and guidance documents, and translate findings into actionable program strate
- gyIdentify regulatory risks early and develop mitigation plans, communicating clearly to program teams and executive leadersh
- ipManage and mentor regulatory staff and oversee consultants and CRO regulatory partners as need
- edContribute to due diligence assessments for business development and licensing opportuniti
es
Qualificati
- onsAdvanced degree in life sciences strongly preferred (PharmD, PhD, MS); RAC certification a p
- lus12+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, with at least 3 years in a strategic or leadership capac
- ityDemonstrated success leading health authority interactions with FDA; EMA and other international agency experience prefer
- redDirect experience authoring and filing INDs and at least one major marketing application (BLA, NDA, or M
- AA)Deep knowledge of FDA and ICH regulations and guidance across the development lifecy
- cleTherapeutic area experience aligned with the company pipeline; biologics or novel modality experience a p
- lusStrong executive presence with the ability to influence cross functional teams and communicate complex regulatory issues sim
- plyComfortable operating in a fast paced, lean environment where strategy and execution go hand in h
Vacancy posted 4 hours ago
Similar jobs that could be interesting for youBased on the Director of Regulatory Affairs in Alameda, CA vacancy
- ...About the Role We are seeking an Associate Director of Regulatory Affairs to support the development and execution of regulatory strategies across our clinical programs. This individual will play a hands on role in health authority interactions, submission planning...Suggested
Precision Point
Alameda, CA4 hours ago - ...neurological disorders, focusing on long-term solutions for the growing aging population. The Role We’re looking for a Director of Regulatory Affairs for our office in Alameda, California who wants to lead, develop and execute the regulatory strategy for Epia Neuro’s...SuggestedFull timeWork at office3 days per week
- Exelixis Inc in Alameda is seeking an Associate Director for Stability Management to lead the stability group and improve drug substance and product testing strategies. The role requires overseeing contracts, reviewing protocols, and managing direct reports. Ideal candidates...Suggested
$195k - $277.5k
Associate Regulatory Affairs Strategy Director (Oncology)Skip to main contentCookies are essential for the operation of our website. By using our website, you agree to the use of necessary cookies. This website uses cookies and similar technologies to offer website functions...SuggestedContract workWork at officeLocal areaFlexible hours- ...Director, Regulatory CMC (Hybrid – San Francisco Bay Area) We are partnering with a well-funded, clinical-stage biotechnology company with... ...individual will serve as a key interface between Regulatory Affairs, CMC, Quality, Technical Operations, and external partners...Suggested
Meet Life Sciences
Alameda, CA2 days ago $200k - $235k
...therapies for people with degenerative retinal diseases independent of genetic mutation. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs will play a critical role in leading and executing global regulatory strategy for our clinical-stage...Ray Therapeutics, Inc.
Berkeley, CA4 days ago$148.7k - $297.3k
The Opportunity This Associate Director Regulatory Affairs will work on‑site out of our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life‑changing products that provide accurate data to drive...- Epia Neuro is seeking a full-time Director of Regulatory Affairs in Alameda, California. This role entails leading the regulatory strategy for Class III implantable neurotechnology, reporting directly to the CEO. The ideal candidate will have extensive FDA experience and...Full time
- Job Title: Regulatory Affairs Strategy Director Location: Alameda, CA Type: Contract Compensation: 140/hr - 155/hr Contractor Work Model: Onsite - Remote in PST Hours: 40.0 Responsibilities Lead the systematic collection, analysis, and dissemination of regulatory...Contract workFor contractorsLocal areaRemote work
$124.5k - $177k
...amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications and submissions to regulatory agencies. Assists senior regulatory leaders with the development of documents to support designations and other health authority...For contractorsLocal areaFlexible hours- Exelixis, Inc. is seeking an Associate Regulatory Affairs Strategy Director based in Alameda, California. This role involves developing global regulatory strategies that align with corporate goals, ensuring timely submissions, and collaborating with stakeholders to mitigate...
$124.5k - $177k
Exelixis Inc in Alameda, California, is looking for a Regulatory Affairs professional responsible for managing regulatory submissions such as IND, NDA, and more. The ideal candidate will have a Bachelor’s degree and at least seven years of relevant experience, or a Master...$248k - $352.5k
...Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well... ...possible expedited pathways. Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory...Contract workWork at officeLocal areaFlexible hoursExelixis
Alameda, CA11 days ago$159k
...ensuring alignment with enterprise policies and external/internal regulatory requirements. It partners cross-functionally to manage... ...Align Regulatory Partners: Collaborate with Legal, Regulatory Affairs, Engineering, Asset Strategy, and Operations to ensure cohesive...Work experience placementWork at officeFlexible hoursPG&E Corporation
Alameda, CA9 days ago$305.7k
...Represent the Alliance as primary contact for Federal, State and regulatory bodies or other relevant parties in issues of compliance.... ...for and by applicable agencies. Coordinate with department directors and managers, legal counsel and the Human Resource Department...For contractorsWork at officeLocal areaAlameda Alliance for Health
Alameda, CA3 days ago$159k
...enterprise policies and external/internal regulatory requirements. It partners cross-... ...Regulatory, analytical, communications or public affairs related position Electric industry... ...information or supervision of a manager or director Ability to analyze complex problems...Contract workWork experience placementWork at officeFlexible hours2 days per week3 days per weekPG&E Corporation
Alameda, CA9 days ago$185k - $263k
Exelixis Inc in Alameda, CA is seeking a GCP/GVP QA Director responsible for ensuring compliance with Good Clinical Practices and Good... ...quality assurance and a strong understanding of regulatory requirements. This position offers a comprehensive benefits package...$133k - $189k
...enhance quality standards and operational efficiency. Essential Duties / Responsibilities Manage inspection logistics to support regulatory inspections, third‑party audits, and mock inspections at Exelixis, including notification process, logistics team, inspection room...Contract workWork at officeLocal areaFlexible hours$190k - $269k
...purpose of the job):*** The Compliance QA Director leads the company’s GxP inspection... ...authority inspections. This role manages regulatory inspections and responses, directs internal... ...with other groups including Regulatory Affairs, Clinical Operations, Drug Safety, Pharmaceutical...Contract workFor contractorsWork experience placementWork at officeLocal areaFlexible hours$100k - $200k
A global healthcare leader in Alameda, CA is seeking a Supervisor for Complaint Handling. In this role, you will supervise non-exempt staff, assign case loads, and ensure compliance with complaint handling procedures. The ideal candidate will have a Bachelor's degree and...- A global healthcare leader is seeking a Regulatory Affairs Manager for their international compliance operations in Alameda, CA. The role involves providing end-to-end support for regulatory activities, ensuring compliance with FDA and international regulations. Candidates...
$190k - $269k
Exelixis, Inc. is seeking a Compliance QA Director in Alameda, California, to lead GxP inspection readiness and regulatory inspections. You will develop inspection readiness plans and manage internal audits while providing compliance guidance and oversight. The ideal candidate...- Exelixis, Inc. is seeking a Senior Director for Regulatory Affairs in Oncology, responsible for developing and implementing global regulatory strategies in alignment with corporate goals. The role involves direct interaction with regulatory authorities, oversight of regulatory...
$80 - $100 per hour
...Hybrid for local candidates Hours: 40.0 Responsibilities Provide compliance oversight for the Global Patient Safety (GPS) and Regulatory Affairs (RA) functions, with a focus on Regulatory Affairs activities. Monitor, assess, and communicate performance against key...Contract workTemporary workFor contractorsLocal areaRemote work$210k - $250k
...leading biopharmaceutical company in Alameda, CA is seeking a Director of Quality Assurance. This role is responsible for leading quality... ..., ensuring compliance with GMP standards, and overseeing regulatory adherence. Ideal candidates have 15+ years in quality management...$148.5k - $209.5k
Assoc Scientific Regulatory Writing Director page is loaded## Assoc Scientific Regulatory Writing Directorlocations: Alameda, CAtime type: Full timeposted on: Posted Todayjob requisition id: JR6365**SUMMARY/JOB PURPOSE** **(Basic purpose of the job):**Leads content development...Contract workWork at officeLocal areaFlexible hours$100k - $200k
## Principal Regulatory Affairs Specialist - Diabetes Care (on-site)Applylocations: United States - California - Alamedatime type: Full timeposted on: Posted Yesterdayjob requisition id: 31145439Abbott is a global healthcare leader that helps people live more fully at...Shift work$100k - $200k
...in Alameda, CA in the Diabetes Care Division, focusing on U.S. regulatory submissions for new product introductions and sustaining... ..., ClassIII medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. Experience with 510(k) applications...Shift work- Abbott in Alameda, CA is seeking a Principal RA Specialist to lead regulatory submissions in diabetes care. This role focuses on advancing diabetes management technologies and requires expertise in regulatory compliance. The position necessitates a Bachelor's degree in...
$100k - $200k
...well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This Principal Regulatory Affairs Specialist - APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on...For contractors
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director of Regulatory Affairs. Be the first to apply!
Related searches
- regulatory affairs director Alameda, CA
- regulatory manager Alameda, CA
- head compliance Alameda, CA
- director global regulatory affairs Alameda, CA
- compliance manager Alameda, CA
- manager regulatory affairs Alameda, CA
- compliance director Alameda, CA
- senior director regulatory affairs Alameda, CA
- sr. manager regulatory compliance Alameda, CA
- senior regulatory manager Alameda, CA