Senior CMC Regulatory Affairs Lead (Remote)
Travere Therapeutics
Columbus, OH
- Remote job
Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global regulatory strategies for small molecule products, focusing on oral solid dosage forms. You will collaborate with Development, Manufacturing, Quality, and Regulatory Operations to ensure successful filings and lifecycle management. The role requires 8+ years in regulatory affairs with CMC emphasis, and experience with FDA, EMA, GCC, and PMDA interactions. #J-18808-Ljbffr Travere Therapeutics
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior CMC Regulatory Affairs Lead (Remote) in Columbus, OH vacancy
- Travere Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule CMC activities from IND through commercialization. The role spans global submissions, Health Authority interactions, and lifecycle management...Remote jobSenior
$165k
...Regulatory Affairs Lead - Manager/Senior Manager/ Ophthalmology Location: Remote Type: Full-time Compensation: $165,000 Position Summary Our biotech client is... ...and Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance,...Remote workSeniorFull timeFor contractorsFidelis Companies
United States-37- Scorpion Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead global CMC regulatory strategies for small molecule drug development and commercialization, with emphasis on oral solid dosage forms. You will own submissions, liaise with global health...Senior
- Anagram Therapeutics, Inc. is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio through all development stages in a fast-paced biotech environment. You will develop regulatory-CMC strategies, coordinate INDs/...Senior
- Pace Analytical Services, LLC is seeking a senior CMC/regulatory affairs professional to lead and execute global regulatory strategies for INDs, IMPDs, CTAs, and filings. The role emphasizes high-quality submissions, documentation, and effective communication with FDA,...Senior
$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...Remote workSeniorLexington Medical, Inc.
United States4 days ago- Scorpion Therapeutics is seeking a Senior Associate, Regulatory CMC to lead strategy, compliance, and submissions... ..., and R&D teams in a fully remote setup. Applicants should have 5+ years... ...biotech/pharmaceutical regulatory affairs with CMC submissions experience in...Remote jobSenior
- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to guide regulatory strategy from... ...clients. The role focuses on leading global CMC activities, client liaison... ...candidate brings 15+ years in Regulatory Affairs/CMC, deep FDA and global regulatory...Remote jobSenior
- Travere Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC across development... ...molecule drugs, with emphasis on oral solid dosage forms. You will lead global submissions, advise on regulatory strategy, and...Remote job
- ...you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval... ...functions, GRDRA region functions and Senior Director or Reg CMC Lead, agree on the regulatory strategy... ...working arrangements, remote work options, and tax assistance...Remote workSeniorHourly payWork at officeLocal areaRelocation packageFlexible hours
Chiesi
Cary, NC2 days ago $212k - $333.19k
...patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part... ...understanding broad concepts within regulatory affairs and implications across the... ..." following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1...Remote workSeniorMinimum wageLocal areaWorldwideTakeda
Boston, MA23 hours ago- Fresenius Kabi USA in Lake Zurich, IL, seeks a Senior Manager, Regulatory Affairs to lead regulatory decision making for complex products, guiding execution... ...-functional teams. Onsite 3 days per week with some remote work, the position collaborates with regulatory agencies...Remote workSenior3 days per week
$132k - $172k
...to pursue our vision of becoming a leading biopharmaceutical company dedicated... ...rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere...Remote workSeniorFull timeTemporary workWorldwideTravere Therapeutics
San Diego, CA2 days ago- Cencora is seeking a Senior Manager, Regulatory Affairs - Animal Health Labeling to lead regulatory labeling across the product lifecycle. The role collaborates with... ...cross-functional experience. The position is remote in the USA with full-time commitment. #J-18808-...Remote jobSeniorFull time
- Legend Biotech US is seeking a Sr. Manager, CQA Lead Auditor to join the Regulatory Affairs team on a remote basis. The role supports GxP audits across GCP, GLP, and GVP, ensuring compliance with global regulations and internal standards, with up to 25% travel outside...Remote jobSenior
- Syneos Health is seeking a Senior Medical Writer Publications - Sponsor Dedicated - Remote Based to lead and manage medical writing deliverables... ...ensure accuracy, maintain regulatory compliance, and mentor... ..., biostatistics, regulatory affairs, and medical affairs. The...Remote jobSenior
- ...Primary Responsibilities 1. Global Regulatory CMC Strategy Lead and drive the global Regulatory CMC strategy... ...10 years of experience in Regulatory Affairs CMC within the biotechnology and/or... ...for this to be Boston-office based, remote East-coast (USA) or hybrid....Remote workSeniorWork at officeFlexible hours
$230k - $270k
...Therapeutics is seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory Affairs and... ...products under development and lead CMC product strategy and provide... ...located in South San Francisco and may be remote up to 2 days per week....Remote workSeniorFull timeContract workInternshipLocal area2 days per weekAllogene Therapeutics
South San Francisco, CA13 days ago$181k - $213k
...visit Position Purpose: The Regulatory CMC Senior Manager is responsible for... ...CMC regulatory strategies, leading lifecycle management initiatives... ...within the Regulatory Affairs department and Technical Operations... ...is a hybrid position, or remote, currently based in Bedford...Remote workSeniorTemporary work- Stoke Therapeutics is seeking a Regulatory CMC Senior Manager to contribute to global regulatory strategies... ...Regulatory CMC. The role focuses on leading CMC regulatory strategies for... ...global submissions. Location is hybrid/remote in Bedford, MA, with a move to Waltham...Remote jobSenior
- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to provide strategic CMC and quality regulatory guidance to biotechnology... ...commercialization and lifecycle management. The role leads global regulatory strategies, advises on pathways and submissions...Remote jobSenior
$160k - $274k
A leading biotechnology company is seeking a Senior Director, Mid-Atlantic CMC, to provide technical and portfolio leadership in a remote capacity. The ideal candidate has a PhD and 8-20 years of experience in the biotech industry, particularly in CMC process development...Remote jobSenior- ...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 analysis...Remote jobSenior
- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...Senior
- Maximus is seeking a Lead Appian Developer to drive design, development, and implementation of complex case management and workflow automation... ..., and ensure compliance with stringent security standards. This remote role requires US citizenship, ability to pass background checks,...Remote jobSenior
- Tailored Brands, Inc. is seeking a Senior Customs Compliance Manager based in Dublin, CA. This role involves leading the customs compliance program for U.S. imports and requires extensive knowledge of customs regulations. Candidates should have over 8 years of relevant...Remote jobSenior
$212k - $333.19k
...you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our... ...to simultaneously driving regulatory approval as well as launch... ...Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT... ...with Takeda’s Hybrid and Remote Work policy.Empowering Our...Remote workSeniorMinimum wageWork at officeLocal areaTakeda
Cambridge, MA23 hours ago- ...oversee centralized filings, advise on asset classifications, and lead a multidisciplinary team across state lines. The role... ...leadership in supervising staff while maintaining timely filings and regulatory compliance. #J-18808-Ljbffr DuCharme McMillen & Associates IncRemote jobSenior
- Syneos Health, Inc. seeks a Senior/Principal Medical Writer with a regulatory focus to lead and manage medical writing deliverables across studies, ensuring accuracy... ..., and maintaining timelines within budget. Remote work is available in the US, UK, and Canada. The...Remote jobSenior
- ...is actively seeking Cultural Resources Lead - Senior Archaeologist for immediate, full-time... ...and support compliance within applicable regulatory frameworks, including NEPA and NHPA.... ...includes a hybrid schedule with up to 40% of remote work, and an alternative work schedule...Remote workSeniorFull timeWork at officeLocal areaImmediate startFlexible hours
Freese and Nichols
Fort Worth, TX23 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior CMC Regulatory Affairs Lead (Remote). Be the first to apply!
Related searches
- senior service associate Columbus, OH
- senior safety specialist Columbus, OH
- senior vice president of business development Columbus, OH
- senior service designer Columbus, OH
- senior sales recruiter Columbus, OH
- senior mulesoft developer Columbus, OH
- senior media manager Columbus, OH
- senior java software engineer Columbus, OH
- senior business manager Columbus, OH
- senior linux systems engineer Columbus, OH