Regulatory Writing Director, Strategy & Submissions
Rigel Pharmaceuticals, Inc.
Rigel Pharmaceuticals, Inc. is seeking a senior Regulatory Writing lead reporting to the Vice President of Regulatory Affairs. This role oversees the technical writing for regional/global submissions, aligning with therapeutic area directions and corporate objectives. Regular onsite presence is required at Rigel’s South San Francisco headquarters, with a structured onsite/hybrid schedule for residents in the area. #J-18808-Ljbffr Rigel Pharmaceuticals, Inc.
Vacancy posted 3 hours ago
Similar jobs that could be interesting for youBased on the Regulatory Writing Director, Strategy & Submissions in South San Francisco, CA vacancy
- ...6-10-22Structure Therapeutics seeks an Associate Director of Medical Writing to lead development of regulatory and clinical documents for its drug pipeline, supporting... ...Biostatistics, and others to ensure high-quality submissions.The position emphasizes compliance with FDA/EMA/...SuggestedRemote work
Structure Therapeutics
South San Francisco, CA3 days ago $243.1k - $314.6k
...thought partner to the Executive Director and a senior cross-functional... ..., and translate agreed strategy into clear recommendations, effective... ...recommendations, and submission coordination; the Executive Director... ...synthesis, executive writing, facilitation and judgment, with...SuggestedPermanent employmentFull timeFor contractorsInterim roleLocal areaGILEAD Sciences
Foster, CA4 days ago$265k - $285k
...comResponsibilities include: Provides regulatory leadership in support of the... ...coordinate, and implement global regulatory strategies and submissions, including CTAs, for new and ongoing... ...eCTD requirementExcellent regulatory writing and review skills with demonstrated experience...SuggestedPlanet Pharma
Brisbane, CA3 days ago$230k - $270k
...a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory... ...and lead CMC product strategy and provide regulatory direction... ...and regulatory submissions are on time and high quality... ...structure including CMC-regulatory writing skills Ability to work in...SuggestedContract workInternshipLocal areaRemote work2 days per weekAllogene Therapeutics
South San Francisco, CA20 hours ago$275k - $355k
...Reporting to the Chief Regulatory Affairs Officer, the Executive Director or VP, Regulatory Affairs... ...will lead regulatory strategy for defined disease area... ...strategies and submissions from pre-IND through regulatory... ..., including excellent writing skills ~ Experience leading...SuggestedTemporary workCasual workLocal areaRemote workWorldwideFlexible hoursErasca, Inc.
South San Francisco, CA4 days ago$324.62k - $420.09k
...patients.RWE is increasingly informing regulatory decisions across development and... ...Evidence (EpiRWE), the Executive Director, Regulatory RWE Strategy and Innovation is a scientific and... ...their respective programs, studies, submissions, and relationships with stakeholders...Full timeFor contractorsLocal areaImmediate startShift workGILEAD Sciences
Foster, CA1 day ago- ...Senior Manager/Associate Director position leading regulatory strategy for hematology-oncology programs at a clinical-stage biotech company. Responsible... ...clinical studies to ensure compliance Prepare regulatory submissions including INDs, NDAs, DSURs, and investigator...
Nurix Therapeutics
Brisbane, CA22 days ago $230k - $250k
...your career, and for what’s beyond. About the Role As the Director, Global Regulatory Strategy Lead - Regulatory Affairs reporting to the Senior... ...tactical guidance and lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD...Work at officeFlexible hours2 days per weekOlema Oncology
San Francisco, CA1 day ago- ...2Structure Therapeutics is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents for its drug programs. The... ...collaboration to ensure compliant, timely submissions.You will manage multiple projects, mentor writers...
Structure Therapeutics
South San Francisco, CA5 hours ago - ...Position details The Manager, Regulatory Affairs, will play a hands-... ...clinical regulatory strategy for ETX-301 in neuropathic pain... ...and coordination of US and EU submissions and support for global health... ...project management, technical writing and communication skills....Remote work
- ...Therapeutics Inc. in California is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents, ensuring compliance with... ...best practices, templates, and processes to improve messaging and submission readiness.#J-18808-Ljbffr
Structure Therapeutics
South San Francisco, CA1 day ago $175k - $200k
...Description We are seeking an experienced Regulatory Affairs professional to join our team... ...high-quality, timely regulatory submissions. The ideal candidate is a proactive team... ...analytical thinking abilities. Excellent writing and editorial skills, with the ability...Odd jobH1bWork at officeFlexible hours- 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...For contractors
- 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....
$180k - $241k
...Function: The Associate Director, Regulatory Affairs supports the development... ...of clinical regulatory strategies and regulatory development... ...regulatory plans, prepare submissions, and support health authority... ..., Biometrics, Medical Writing, CMC, and other functions....Remote workWorldwideRelocation packageZai Lab (US) LLC
South San Francisco, CA20 hours ago- ...Executive Director, Regulatory Strategy About the Company Clinical-stage biopharmaceutical company developing innovative, transformational... ...expanding the regulatory organization to support various global submissions. This is a unique opportunity to shape the team and its...
- ...limited to):Develop and implement regulatory product strategiesRepresent... ...regulatory guidance and strategy including identifying and... ...contingenciesPlan, prepare, and review submissions to required authorities... ...preferred.Experience writing or updating processes.Experience...Full timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours
Kite Pharma
San Mateo, CA4 days ago $175k - $195k
...Senior Manager (SM), Regulatory Affairs Labeling will... ...global regulatory labeling strategy and documentation for... ...report to the Senior Director, Global Commercial... ...colleagues on regulatory submissions of labeling documents... ...industry.Experience with writing, developing,...Local areaFlexible hoursMirum Pharmaceuticals
Foster, CA3 days ago- ...All Jobs Director / Senior Director / Executive Director, Regulatory Affairs Director / Senior Director / Executive... ...Affairs leads regulatory strategy and submission execution for one or more oncology... ...Operations and Medical Writing to ensure submissions meet global...Full timeRemote work
bbotx inc.
South San Francisco, CA20 hours ago $218.06k - $327.09k
...Job Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and... ...implementation of the global regulatory strategy for CGT products of high... ...ofhighcomplexity, fromcurrentstage through BLA submission.Mayserveindual-roleas GRL...Hourly payTemporary workWorldwideFlexible hours3 days per weekAstraZeneca GmbH
South San Francisco, CA20 hours ago$216.4k - $234.8k
...science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and... ...— from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging...Odd jobLocal areaFlexible hoursShift work$180k - $212k
Reporting to the Vice President of Regulatory Affairs, this position is specifically responsible for the technical writing oversight of regional and/or global regulatory submissions and ensures strategies are in accordance with therapeutic area direction and corporate objectives...Local areaRemote workFlexible hours- Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco. The ideal candidate will possess a Master’s degree in a life science discipline, with a preference for a PhD, along with at least 10 years in regulatory...
$187.8k - $208.64k
...Senior Manager / Associate Director Regulatory Affairs (Strategy Hematology Oncology) Nurix Therapeutics... ...treatments at the forefront of patient care writing medicines next chapter with a new... ...of regulatory application submissions Conduct research and stay up-to-...Full timeFor contractors- ...Managing Director, Wealth Strategy About the Company Offers family office services and sophisticated estate and wealth planning for high-... ...Wealth Strategist will also be involved in client meetings, writing and publishing expert articles, and providing training and...Work at office
$187.8k - $208.6k
Shape the CMC regulatory path for Nurix's small molecule portfolio... ...room at the Associate Director level to own strategy and mentor junior regulatory... ...) content for regulatory submissions, including IND/IMPD and equivalent... ...and scientific/technical writing skills Ability to manage...Local area$230k - $250k
...seriously.POSITION SUMMARYThe Director, Regulatory Project Management provides... ...for Regulatory Medical Writing (RMW) Department deliverables... ..., high-quality regulatory submissions of original applications (i... ...contribute to regulatory submission strategy, working in close...Local areaMirum Pharmaceuticals
Foster, CA3 days ago$141.93k - $177.41k
...is looking for an experienced AI operator & leader to own the strategy and execution of AI-powered customer experience. You’ll lead the... ...measurable outcomesProduct-minded builder: equally comfortable writing a requirements doc, configuring a platform, and partnering with...Work at officeRemote workWork from homeShift workBrex
San Francisco, CA3 days ago$209.7k - $389.4k
...role is a valuable part of our Contract Strategy Implementation (CSI) team within Channel... ...access strategies.The OpportunityThe Sr. Director, Contract Strategy Implementation (Payer... ..., market access models, and government/regulatory contracting guidelines.Operational & Technical...Full timeContract workLocal areaRelocation packageGenentech
South San Francisco, CA15 hours ago$243.1k - $314.6k
...thought partner to the Executive Director and a senior cross-functional... ...and translate agreed strategy into clear recommendations effective... ...recommendations and submission coordination; the Executive Director... ...synthesis executive writing facilitation and judgment with...Permanent employmentFull timeFor contractorsInterim roleLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Writing Director, Strategy & Submissions. Be the first to apply!
Related searches
- head compliance South San Francisco, CA
- regulatory & compliance manager South San Francisco, CA
- regulatory affairs manager pharmaceutical South San Francisco, CA
- associate director compliance South San Francisco, CA
- regulatory affairs director South San Francisco, CA
- manager regulatory affairs South San Francisco, CA
- senior regulatory manager South San Francisco, CA
- compliance director South San Francisco, CA
- regulatory cmc manager South San Francisco, CA
- compliance manager South San Francisco, CA