Regulatory Affairs CMC Lead — Associate Director (Strategy)
AbbVie
AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate with R&D, Operations and Global Regulatory teams to enable first-pass approvals and ensure compliant content for INDs/CTAs and variations. You will also guide agency meetings, manage change controls, and mentor team members. The role requires extensive pharmaceutical regulatory experience, strong communication, and the ability to operate in a #J-18808-Ljbffr AbbVie
$170k - $230k
Position Title: Associate Director, Regulatory Strategy Reports To: Executive Director, Regulatory... ...in eCTD format Lead or support preparation of... ...functional teams (Clinical, CMC, Nonclinical, Quality) on... ...including roles in regulatory affairs within biotechnology or...Suggested- ...YouTube. Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and... ...patients. Prepares CMC regulatory strategies that enable first pass... ...regulatory affairs department. Leads initiatives internal to RA...Suggested
- Kardigan is looking for an Associate Director, Regulatory Strategy to support regulatory strategies and ensure high-quality deliverables. You will collaborate... ...has at least 6 years of experience in regulatory affairs, particularly within biotech or pharmaceuticals, and...Suggested
- ...Therapeutics Inc is seeking a leader to organize and manage CMC strategies, deliverables, and timelines for programs, including oversight... ...The role requires coordinating with technical leaders, program directors, and cross-functional teams to integrate CMC deliverables...Suggested
$180k - $210.5k
...attempted to protect humankind.*LEAD WITH HEART: Everyone leads... ...multi-product global regulatory CMC strategies for investigational products... ...Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or... ...guidelinesReports to: Executive Director, CMC RegulatoryLocation:...Suggested- ...based in South San Francisco, seeks a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for our US and global... ...reports to the Executive Director, Regulatory Affairs and collaborates across Tech Ops to align...
- ...Therapeutics is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to shape regulatory strategies for manufacturing across... ...Director of Regulatory Affairs and will own CMC... ...office. The candidate will lead CMC strategy, manage regulatory...Work at office2 days per week
- Marea Therapeutics, Inc. is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies and submissions for US and global... ...to the Executive Director of Regulatory Affairs and requires strong strategic thinking and...Full time
- Erasca, Inc. is seeking a Senior Manager or Associate Director of CMC Regulatory Affairs to lead regulatory activities for IND/CTA development, with future MAA/NDA/BLA planning. This high-profile role requires an independent, self-directed regulatory professional with...
$220k - $270k
ORIC Pharmaceuticals is seeking a Senior Director/Director of CMC Regulatory Affairs to lead CMC regulatory activities in South San Francisco. The ideal candidate... ...to ensure compliance with CMC regulatory strategies for oncology products. The anticipated salary range...- 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...
$159k - $207k
...Denali is founded on the collaboration of leading scientists, industry experts, and... ...responsible for organizing and managing CMC strategies, deliverables, and timelines for Denali... ...closely with our technical leaders, Program Directors, and cross-functional project teams to...Contract workLocal area- ORIC Pharmaceuticals, Inc. is seeking a Senior Director/Director, CMC Regulatory Affairs to lead global CMC regulatory strategies and documentation for oncology programs. Based in South San Francisco, you will partner with Regulatory Affairs, Quality, and Clinical teams...
$193k - $246k
...point.insitro is seeking an (Associate) Director, Drug Product Operations to lead drug product strategy and execution for our early... ...working closely with other CMC roles, Regulatory, and Clinical Operations.... ...Drug Substance, Regulatory Affairs, Quality, and Clinical OperationsProgram...Work at officeLocal areaRemote workHome officeFlexible hours3 days per week- ...specialty cardiovascular biopharmaceutical company, seeks an Associate Director of Regulatory Affairs to lead regulatory activities across development stages and interact with health authorities. You will drive strategies for assigned programs, prepare high-quality...
- The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) leads initiatives to develop and manage regulatory strategies for CMC submissions, including INDs/CTAs and amendments. This role builds relationships across Regulatory Affairs, Operations...
$210k - $240k
...by ensuring that CMC development,... ...may assist with regulatory filings. This position... ...to Senior Director, CMC Program Management... ...project plans, leading the integrated CMC strategy. Translate... ...Development, Regulatory Affairs, Quality, Supply... ...range for Associate Director level...Full timeH1b- Denali Therapeutics Inc. is seeking an Associate Director of Biosample Operations in South San Francisco... ...data quality for Phase I-IV trials. Lead vendor oversight, guide biosample strategy, and partner with QA/Regulatory to ensure GCLP and GCP compliance across clinical...
$182.07k - $235.62k
...come.Key Responsibilities:The Associate Director, Strategic Sourcing &... ...This includes ownership of the strategy, selection, risk, and performance... ...for indirectly leading and influencing others, bidding... ...product team (PDM subteam and/or CMC) needs for the selection of...Full timeContract workFor contractorsLocal areaRemote work$198k - $257k
...secured partnerships with leading global biopharmaceutical companies... ...Primary Function: The Associate Director, Regulatory Affairs supports the development... ...of clinical regulatory strategies and regulatory development... ..., Medical Writing, CMC, and other functions. Partner...Work at officeWorldwideRelocation package- Veratherapeuticsinc seeks a Senior Manager, Regulatory CMC to manage regulatory submissions and activities within a dynamic team. This role... ...regulatory knowledge, organizational skills, and the ability to lead cross-functional projects. Candidates should have at least 6...
- TCG Labs‑Soleil is seeking a Senior Manager / Associate Director, Process Development to lead CMC biologics DS/DP process development and manufacturing efforts... ..., and cross‑functional collaboration with QA, regulatory, and external CDMOs. The role emphasizes strong project...
$185k - $225k
Associate Director of Brand StrategyCooley is seeking an Associate Director of Brand Strategy to join the Marketing and Client Development team.Position summary: This role is part... ...: Brand Strategy & Positioning: Lead the development and evolution of the firm’...Full timeTemporary workWork at officeImmediate startFlexible hoursWeekend work$130k - $150k
...everyone's role to make health more human.About the Role:The Associate Director, Brand Strategy position serves within the Brand Strategy team by... ...the strategic discipline forward. Most importantly, you lead collaboration across many different working styles and perspectives...Remote workFlexible hours$150k - $320k
...Valued at US$11 billion and backed by world-leading investors including T. Rowe Price, Visa... ...’s build what’s next.About the teamThe Strategy & Operations team at Airwallex plays a... ...’ll doAirwallex is seeking a seasoned Associate Director of Revenue Strategy to lead high-stakes...Temporary workLocal areaWorldwide- ...week on average. Position Summary The Associate Director, Regulatory Affairs Project Planning & Coordination is... ..., endorses, and executes regulatory strategy. This role will also be involved in... ...trial public disclosure tracker and lead periodic cross‑functional status reviews...Work at officeLocal areaRemote workNight shift3 days per week
- Ultragenyx is hiring for a Director, CMC Quality Control - Small Molecules... ...and commercialization. You will lead governance for CMOs/CLs, ensuring compliant QC strategies, data integrity, and phase-... ...-functional collaboration for regulatory submissions, inspections, #J-...
- IDEAYA Biosciences, Inc. in South San Francisco is looking for a Senior Director, Medical Writing to lead the strategy and development of clinical and regulatory documents across oncology programs. This role entails overseeing a medical writing team and managing projects...
- .... Position: Senior Manager / Associate Director, Regulatory Affairs Location: South San Francisco... ...role spans both Clinical and CMC (Chemistry, Manufacturing, and... ...develop proactive mitigation strategies to keep programs on track Lead or support health authority interactions...Work at officeShift work
$174k - $268k
Kardigan is seeking an Associate Director of Insights & Analytics in South San Francisco, responsible for generating commercial insights to inform strategy and development. The role requires leading market research and analytics initiatives, collaborating across various...
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