Remote Senior Director, Quality & CMC Regulatory Strategy
Piper Companies
- Remote job
Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to provide strategic CMC and quality regulatory guidance to biotechnology and pharmaceutical clients from development through commercialization and lifecycle management. The role leads global regulatory strategies, advises on pathways and submissions, and oversees INDs, global filings, and lifecycle activities while collaborating with cross-functional teams and mentoring regulatory professionals. #J-18808-Ljbffr Piper Companies
- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to guide regulatory strategy from development through lifecycle management for biotechnology and pharmaceutical clients. The role focuses on leading global CMC activities, client liaison, and...Remote jobSeniorRegulatory
- Piper Companies seeks a Senior Director, Quality & CMC Regulatory Strategy to provide strategic CMC and quality regulatory guidance across biotech and pharmaceutical client programs, from development to lifecycle management. The role leads global regulatory strategies,...SeniorRegulatory
$200k - $290k
...a highly self-motivated Director/Senior Director of CMC Quality Operations to join our team... ...Operations Location: Remote (U.S.) What You'll Do Faeth... ...development of clinical assets and regulatory submissions. This... ..., re-testing strategies, and bridging activities...Remote workSeniorRegulatoryContract workFlexible hours- ...listed clinical-stage oncology company, seeks a Director/Senior Director of CMC Quality Operations. This remote US role collaborates across CMC, Technical Operations... ...manage stability programs, method transfer, and regulatory reporting, ensuring cGMP compliance, robust data...Remote jobSeniorRegulatory
- ...motivated analytical development scientist and quality control professional to manage... ...contract manufacturing sites and support regulatory submissions. The role requires extensive... ...Drug Substance, and Drug Product teams. Remote (U.S.) with potential travel. #J-18808-...Remote jobSeniorRegulatoryContract work
$250k - $290k
Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to join a leading regulatory consulting and drug development services organization... ...drug development, regulatory leadership, commercialization. #LI-RB1 #LI-REMOTE #J-18808-Ljbffr Piper CompaniesRemote workSeniorRegulatory- ...Senior Director, Biologics CMC (4 days onsite, 1 day remote) Position Summary Reporting to the Head of CMC, the... ...manufacturing, analytical development, quality, regulatory CMC, and external... ...Develop and execute integrated CMC strategies aligned with overall program...Remote workSeniorRegulatoryFull time
- Stoke Therapeutics is seeking a Regulatory CMC Senior Manager to contribute to global regulatory strategies, lifecycle management, and... ...across programs. Reports to the Director of Regulatory CMC. The role... .... Location is hybrid/remote in Bedford, MA, with a move to...Remote jobSeniorRegulatory
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for small molecule products, focusing on oral solid... ...collaborate with Development, Manufacturing, Quality, and Regulatory Operations to ensure successful...Remote jobSeniorRegulatory
- Scorpion Therapeutics is seeking a Senior Associate, Regulatory CMC to lead strategy, compliance, and submissions for biologics and... ...compliance. This role collaborates with Quality, Manufacturing, and R&D teams in a fully remote setup. Applicants should have 5+ years in...Remote jobSeniorRegulatory
- Kardigan, Inc. seeks a Senior Director, CMC Regulatory to lead regulatory activities for late-stage cardiovascular assets. You will define and execute CMC strategies, interact with global health authorities, and ensure timely, compliant submissions across programs. The...SeniorRegulatory
- ...doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post... ...region functions and Senior Director or Reg CMC Lead,... ...on the regulatory strategy for the GRD products... ...management of quality variations.Proficient... ...working arrangements, remote work options, and...Remote workSeniorRegulatoryHourly payWork at officeLocal areaRelocation packageFlexible hours
- Kardigan seeks a Senior Director, CMC Regulatory to lead the development and execution of CMC regulatory strategies driving global submissions and interactions with health authorities. This role reports to the Head of CMC Regulatory and is based in South San Francisco,...SeniorRegulatory
$200k - $250k
...Senior Director, Regulatory Strategy Consulting 4 days ago – Be among the first 25 applicants... ...at scale. Work Location: Remote position. Travel may be... ...teams / vendors to ensure quality, timely, and compliant regulatory... ..., and/or regulatory CMC. Experience across...Remote workSeniorRegulatoryFull time- Role Senior Manager, Regulatory Strategy (US RA) at Lundbeck, focusing on US regulatory development and approval... ...experience, and familiarity with CMC. High-value specifics High-value specifics... ...with FDA. Work setup Work setup: Remote within the US, with ~5% domestic travel...Remote workSeniorRegulatoryWork at office
$232k - $290k
...pride. At Baxter, every quality decision has the... ...products every day. As Senior Director, Quality Assurance for... ...will lead Quality strategy and performance across... ...organizational capability, regulatory compliance, and... ...headquarters. We will consider remote candidate, although...Remote workSeniorRegulatoryFull timeTemporary workFlexible hours- ...Job Description The Senior or Executive Director, Global Regulatory Strategy is a key leadership role... ...strategy with clinical, CMC, and commercial objectives... ...development of high-quality briefing materials, ensuring... ...\n \n \n This is a remote role operating from the...Remote workSeniorRegulatory
$184.6k - $277k
...DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for... ...Monitor and interpret cGMP regulatory guidelines and trends in the... ...enterprise-level thinking and strategy direction to staff and... ...designated as: 1. Hybrid: work remotely up to two days per week;...Remote workRegulatoryFull timeWork experience placementSummer workFlexible hours2 days per week$230k - $270k
...seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global... ...Regulatory Affairs and Clinical Quality group to support products... ...and lead CMC product strategy and provide regulatory direction... ...San Francisco and may be remote up to 2 days per week....Remote workSeniorRegulatoryFull timeContract workInternshipLocal area2 days per week- Role: Senior Director of Quality Assurance overseeing clinical quality in biopharma... ...develop risk-based QA strategies oversee audits of CROs and... ...manage compliance risks lead regulatory inspections review... ...international travel Work Setup remote USA. #J-18808-Ljbffr...Remote workSeniorRegulatory
$181k - $213k
...Position Purpose: The Regulatory CMC Senior Manager is... ...global CMC regulatory strategies, leading lifecycle management... ...position will report to the Director of Regulatory CMC.... ...Matter Experts, for Quality Modules. Effectively... ...hybrid position, or remote, currently based in Bedford...Remote workSeniorRegulatoryTemporary work- Indomo is seeking an experienced CMC consultant to execute CMC strategy and operations on a fractional basis,... ...CDMOs and a lean internal team. The senior expert will provide strategic... ...and device-enabled delivery, with regulatory readiness at IND/NDA milestones and...Remote jobRegulatory
- ...future. Your Role The Quality Director will serve as the strategic... ...the highest standards of regulatory compliance, product quality,... ...MSAT initiatives with quality strategy, technical input, and... ...efforts between onsite and remote teams Benefits Offering...Remote workSeniorRegulatoryTemporary workInternshipLocal area
- ...Description Role Summary The Manager/Senior Manager, CMC Quality Control (QC) is responsible for... ...Analytical Development, Technical Operations, Regulatory Affairs, Quality Assurance, and... ...understanding of analytical control strategy development and specification management...SeniorRegulatoryContract workWork at officeWork from home2 days per week
$230.72k - $345k
Remote Full time R12948 Position Summary The Senior Director, Global Regulatory Strategy is a senior regulatory executive responsible for providing... ...strategic alignment and quality for all submissions Drive... ...Medical Affairs, Regulatory CMC, Quality, Safety,...Remote workSeniorRegulatoryFull timeTemporary workLocal areaWorldwideFlexible hours- Travere Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule CMC activities... ...candidate will partner with Development, Manufacturing, Quality, Analytical Development, and Regulatory Operations to align...Remote jobSeniorRegulatory
- ...Business Senior Strategy Analyst Location: Buffalo, NY - Onsite 4 days, 1 day remote Role Overview The team is supporting business servicing and modernization... ...project documentation aligned with business and regulatory requirements. Drive discussions with...Remote workSeniorRegulatory
$200k - $250k
A leading regulatory consulting firm is seeking a Senior Director for Regulatory Strategy Consulting to architect global regulatory strategies and lead cross-functional teams... ...development and client engagement. This is a remote position but may require travel. Full-time...Remote jobSeniorRegulatoryFull time- Pulmovant seeks a Senior Director of Regulatory Affairs to lead global regulatory strategy and ensure timely, compliant submissions for pulmonary programs. You will manage interactions with the FDA and other global health authorities, oversee NDA/MAA submissions, and guide...Remote jobSeniorRegulatory
- ...the treatment of back pain. Role and Responsibilities: Senior Director/Director, CMC/GMP Quality Assurance: We are looking for an enthusiastic and... ...Technical Officer, Chemistry, Manufacturing and Controls, Regulatory CMC, and Quality Assurance. The GMP QA FTE candidate...SeniorRegulatoryFull timeContract workWorldwide
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