CMC Regulatory Strategy Executive Director
Allakos
A biopharmaceutical company in Redwood City is seeking an Executive Director of Regulatory Affairs CMC to lead the regulatory strategy for drug products. The ideal candidate will have 15 years of regulatory CMC experience and a successful track record in preparing BLAs. This role involves close collaboration with internal teams and regulatory authorities to ensure compliance and optimize submission processes. Competitive salary based on experience. #J-18808-Ljbffr Allakos
- Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic clinical... ...for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and...Regulatory
$290k - $320k
...committed to advancing novel therapeutic strategies that address this rare and complex... ...Familiarity with current legal and regulatory landscape pertinent to the pharmaceutical... ...currently anticipates the base salary for the Executive Director, Payer Strategy and Engagement role...RegulatoryContract workWork at officeLocal areaHome office3 days per week- ...President of Chemistry, Manufacturing, and Controls (CMC) to define and execute CMC strategy. This executive role involves managing drug development... ...overseeing outsourced manufacturing, ensuring compliance with regulatory standards, and leading a high-performing team. The...Regulatory
$290k - $310k
...Manufacturing, and Controls (CMC) Juvena Therapeutics is seeking... ...strategic leader to join our executive team as the Vice President of... ...the comprehensive CMC strategy for our portfolio from discovery... ...lead optimization through regulatory filings, formulation optimization...RegulatoryContract workWork at officeRemote work- ...BeOne Hematology Franchise is seeking a Senior Director/Executive Director to lead non-personal promotion strategy and execution. The Hematology Franchise has a market... ...media. Ensure compliance with all Legal, Regulatory, Privacy, and Pharmacovigilance requirements....RegulatoryWork at office
$300k - $350k
...making. Summary: The Executive Director, Quality Assurance, External... ...and executing the quality strategy across Vaxcyte's global network... ...are compliant with global regulatory requirements and Vaxcyte quality... ...Technical Operations, CMC, Regulatory, and Supply Chain...RegulatoryContract workRelocationRelocation package2 days per week3 days per week- A leading game development company is searching for a Senior Director of Executive Compensation in Redwood City, California. The ideal candidate will shape and manage executive compensation programs, collaborating with senior leadership while offering innovative solutions...
$238.9k - $281.1k
...patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit Lead the preparation of CMC Regulatory documents from pre-IND to marketing authorization submissions in multiple therapeutic areas, molecules, and regions. This...RegulatoryFull time3 days per week$294k - $367k
...We are seeking an accomplished, strategic and execution-oriented leaders, Vice President, Global CMC Regulatory, reporting to SVP of Pharmaceutical Development... ..., manufacturing, and controls (CMC) regulatory strategy and execution across all development programs and...RegulatoryFull timeLocal area$180k - $210.5k
...and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation... ...and ICH) guidelines Reports to: Executive Director, CMC Regulatory Location: San Carlos, CA / US...RegulatoryRemote work$311k - $357k
...RevMed is seeking an experienced privacy executive to support RevMed's business. The Executive Director, Global Privacy will lead the strategy, development, and execution of the... ...senior executives on global privacy risks, regulatory developments, and data governance....RegulatoryFull timeLocal areaWorldwide- # Executive Director, Admissions & Financial Aid at Loyola Marymount Universityby | Apr 27, 202... ...role in shaping and guiding enrollment strategy at Notre Dame de Namur University.... ...ensuring effective enrollment management and regulatory compliance. The role operates at an...Regulatory
- ...Executive Director or Vice President, Healthcare Law About the Company Esteemed life science... ..., distribution, licensing, and regulatory submissions. This role requires a professional... ...in driving legal cross-functional strategy and will be a critical part of the team...RegulatoryWork at office
- Planet Pharma Group is seeking a Director of Regulatory Affairs in Redwood City, California. This role involves delivering regulatory strategy for oncology programs, mentoring teams, and ensuring resource readiness for late-stage programs. Candidates should have over 12...Regulatory
$168k
Loyola Marymount University is seeking an Executive Director for Admissions and Financial Aid to lead enrollment strategy and oversee operations. This executive role combines... ...in admissions, financial aid, and regulatory compliance with a strong leadership background...Regulatory$230k - $290k
...Title: Senior Director/Executive Director, Scientific Communications Reports to: Vice President... ...integrated scientific communication strategies across the company's oncology... ...Translational Medicine, Biostatistics, Regulatory Affairs, Legal, Compliance, Commercial...RegulatoryWork experience placementFreelanceLocal area$265k - $331k
...pathway. The Opportunity: The Executive Director of GCP QA is a senior leadership role... ...and executing the global GCP quality strategy across clinical development programs. This position ensures compliance with regulatory requirements, industry standards, and...RegulatoryFull timeContract workLocal area$311k - $357k
...Executive Director, Healthcare Law and Market Access Revolution Medicines is a late-stage clinical... ..., distribution and licensing, and regulatory submissions. In addition, the position... ...Medicines' U.S. Market Access legal strategy in support of commercialization, patient...RegulatoryFull timeLocal areaFlexible hours- ...leading clinical-stage biotech company is seeking a Director/Senior Director for the Lirentelimab CMC team in Redwood City, CA. This role involves leading... ...expertise, leadership capabilities, and experience in regulatory submissions. The position offers a competitive...Regulatory
$265k - $331k
...are seeking a skilled and experienced Executive Director (ED) of Global Patient Safety (GPS) Quality... ...and Compliance is responsible for the strategy, development, oversight, and execution... ...skills to ensure compliance with regulatory requirements to safeguard patient well...RegulatoryFull timeContract workLocal area- Position: Senior/Executive Medical Director, Medical Affairs and Clinical Development- Allergy/Gastroenterology... ...Your Role Provide leadership of the strategy and development of Lirentelimab’s... ...plans, safety data reviews, and regulatory licensing applications Ensure safety...RegulatoryShift work
$281.01k - $363.66k
...Executive Director, Purification Process Development At Gilead, we're creating... ...management. This role sets strategy and provides technical... ...Technical Development, Quality, Regulatory, Manufacturing, and Supply... ...Development, Quality, CMC Regulatory Affairs, and Manufacturing...RegulatoryLocal area$265k - $331k
...Executive Director, Early Clinical Development Redwood City, California, United States Revolution... ..., from early-stage studies to regulatory submissions and potential commercialization... ...authoring and clinical development strategy(ies) and bringing forward for...RegulatoryFull timeLocal area$270k - $320k
Overview Executive Director, Global Patient Safety Operations at Revolution Medicines, Redwood... ...Inhibitors used in combination treatment strategies. Responsibilities Develop and... ...and approval for drug‑safety related regulatory reports and clinical study documents (...RegulatoryFull timeContract workLocal area$280k - $310k
...Senior Director, Regulatory Affairs CMC Foster City Mirum Pharmaceuticals is a biopharmaceutical company... ...submissions: strategic planning, execution, and ensuring quality and accurate... ...implementation of all regulatory CMC strategies to support market applications, post...RegulatoryLocal area- ...Executive Director, Biostatistics Our client is an international biopharmaceutical company focused on improving patients' lives by identifying... ...statistical expertise and leadership in the development and regulatory approval process efforts for our clients Pharmaceuticals'...Regulatory
- ...Associate Director, Cmc Regulatory Affairs For Biologics At Gilead, we're creating a healthier world for all people. For more than 35 years... ...at Gilead you will be responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio. This...RegulatoryLocal area
$209.1k - $276.8k
Corcept Therapeutics is looking for a Director of Health Economics and Outcomes Research... ...California. The role involves leading the HEOR strategy across oncology products, responsible... ...evidence and ensuring alignment with regulatory requirements. Applicants should have a PhD...Regulatory- Position: Director / Senior Director, Lirentelimab CMC Team Leader Location: Redwood City, CA... ..., business, quality, regulatory representatives who also... ...will support successful execution of these critical activities... ...to overall project strategy and executes the appropriate...Regulatory
- ...The Executive Director, Global Medical Affairs (ex-China) for Hematology will report directly... ...implementing all aspects of the global medical strategy for one or more assigned BeOne... ...Acts in line with all applicable legal, regulatory and company standards, and codes of...RegulatoryLocal area
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