Associate Director, CMC Regulatory Affairs - Global Submissions (Remote)
Ionis-Pharmaceuticals
Ionis Pharmaceuticals, Inc. in Carlsbad, CA, is seeking an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds. The role collaborates with cross-functional teams, partners, and vendors to deliver accurate regulatory documentation within timelines and to liaison with authorities for timely approvals. The candidate will lead complex submissions, oversee post-approval changes, and maintain current knowledge of applicable
#J-18808-Ljbffr$154.4k - $242.55k
...worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization,... ...of robust and accurate submissions.Develops constructive relationships... ...Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1...Remote workMinimum wageLocal areaWorldwide$164k - $213k
...Associate Director, Regulatory Affairs CMC At Insmed, every moment and every patient counts... ...who joins in. As a global biopharmaceutical company... ...and coordinate regulatory submissions to support projects in development... ...Work This is a fully remote role. It can be performed...Remote workTemporary workFlexible hours- ...the better. Chiesi Global Rare... ...doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval... ...a broad range of submissions to Regulatory Authorities... ...functions and Senior Director or Reg CMC Lead,... ...arrangements, remote work options, and...Remote workHourly payWork at officeLocal areaRelocation packageFlexible hours
$181.16k - $224.72k
...making our onsite, hybrid and remote work environments a place... ...employees can thrive. ASSOCIATE DIRECTOR, CMC REGULATORY AFFAIRS Summary This individual’s... ...to establish and execute global CMC regulatory strategies... ...requirements for global submissions, (2) work independently...Remote work- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations... .... As the Regulatory CMC lead for these... ...collaboration with CMC and global development teams,... ...requirements for submission to US and ex-US regulatory... ...that balances remote work flexibility with...Remote workContract work
- General Information Name: Associate Director, Regulatory Affairs - CMC Ref #: 15322 Posting... ...Schedule: Full time Remote Work: In office Job: RI... ...responsible for leading the global regulatory CMC strategy... ...CMC documentation and submissions in adherence to relevant...Remote workPermanent employmentFull timeTemporary workWork at office
$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... ...and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the...Permanent employmentFull timeWork at officeWork from home- Angitia Biopharmaceuticals seeks a Director of Global Regulatory Affairs to drive regulatory strategy for development... ...programs, coordinating with clinical, CMC, safety, statistics, and operations. You will lead global submissions and health authority interactions, guiding...Remote job
- ...is seeking a highly technical Regulatory Affairs Manager / Senior Manager in... ...Gaithersburg, MD for a 100% hands-on CMC role. The position is hybrid... ...author and coordinate CMC submissions, manage regulatory strategy, and collaborate with global teams and CMOs/CROs. The...
$135.3k - $202.9k
...advancement across the globe.Scope: The Associate Director, Global Regulatory Affairs Lead is responsible for the... ...regulatory sub-team.Drive the regulatory submission in your respective region. Ensure... ...with Monday and Friday offered as remote flexible.Pay Range for this...Remote workLocal areaMonday to FridayFlexible hours$154.4k - $242.55k
...for the delivery of global regulatory strategies to support... ...required maintenance submissions/notifications to ensure... ...Global Regulatory Affairs (GRA) function in senior... ...and supporting trade association working groups.... ...communicationLocation: Remote within the USTakeda Compensation...Remote workMinimum wageLocal area$142.5k - $256.5k
The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... ...and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the...Permanent employmentWork at officeLocal areaWork from home$235k - $280k
...Job Title: Senior Director, Global Regulatory Affairs Reports to (Title): VP, Hengrui... ...Hybrid for NJ/MA candidates & Remote for out-of-state Job... ...NDA, BLA, and MAA submissions, providing an exceptional... ...clinical pharmacology, and CMC, ensuring integrated regulatory...Remote workFull timeMonday to Friday$150k - $210k
...position will contribute regulatory CMC experience to Edgewise cardiovascular... ...needed for regulatory submission activities for US and global assigned products. The... ...with Regulatory Affairs, CMC, and Quality to ensure... ...experience working in a remote environment. ~ Able to...Remote workFull timeFor contractors$284k - $302k
...Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide strategic... ...including Clinical, CMC, Biometrics, and Translational... ...(CTR) and CTA submissions.Serve as the primary... ...in San Diego office. Remote permitted upon approval...Remote workFull timeSummer workWork at officeRelocationRelocation packageShift work$222k - $303k
...person who joins in. As a global biopharmaceutical company... ...We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us... ...quality, compliant, on-time submission activities for initial... ...You’ll Work This is a fully remote role. It can be performed...Remote workFull timeLocal areaFlexible hours$189.7k - $237.1k
...Join Acadia as the Director, Regulatory CMC and play a critical role... ...develop and execute global regulatory CMC strategies... ...the CMC regulatory affairs activities for... ...MAAs and amendments for submission to regulatory authorities... ...independently from remote locations. The employee...Remote workFull timeWork at officeLocal areaWorldwideShift workNight shiftDay shift3 days per week$180k - $230k
...Position: Director, Global Regulatory Affairs Department: Development - Regulatory... ...Affairs Location: U.S (Remote) with up to 20% domestic travel... ...Development, Nonclinical, CMC, Safety, Biostatistics,... ...of major regulatory submissions, including INDs, CTAs, amendments...Remote jobFor contractorsWork from homeOverseas- Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval change management and regulatory submissions across small molecule and biologics. This... ...requires 10+ years in biopharma with deep global HA regulatory experience, an advanced...
- Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC, to lead and oversee regulatory activities for CMC and Quality, coordinating worldwide submissions and agency communications. The role requires 10+ years in pharma/biotech with strong EU/ROW regulatory...Work at officeWorldwide
$166.4k - $249.6k
...Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...-quality regulatory submissions, while serving as the... ...Pharmacy, Regulatory Affairs, or related life science... ...designated as: 1. Hybrid: work remotely up to two days per...Remote workFull timeSummer workFlexible hours2 days per week$230k - $270k
...seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory Affairs and Clinical Quality... ...requirements and regulatory submissions are on time and high quality. The... ...in South San Francisco and may be remote up to 2 days per week. Responsibilities...Remote workFull timeContract workInternshipLocal area2 days per week$154.4k - $242.55k
...worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will... ...programs, oversee major submissions, and guide cross-... ...concepts within regulatory affairs and implications across the... ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI...Remote workMinimum wageLocal areaWorldwide$222k - $303k
...person who joins in. As a global biopharmaceutical company... ...We’re looking for a Senior Director, Regulatory Affairs CMC to help us expand what’s possible... ..., and manage regulatory submissions for compounds in various... ...Work This is a fully remote role. It can be performed...Remote workFull timeLocal areaWorldwideFlexible hours- Enigma Search in the United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small molecules and monoclonal antibodies... ...with CMC, Quality, and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD, ensure regulatory...
$189.5k - $235k
Vacancy Name Director, Regulatory Affairs-Global Regulatory Lead Vacancy No... ...Radnor, PA, Oxford, UK, Remote, US Department... ...development, IND development/submission /maintenance, BLA/... ...activities associated with the project teams... ...trial labelling and CMC submissions for regulatory...Remote workFull timeWork at officeLocal areaWorldwideNight shift$222k - $303k
...person who joins in. As a global biopharmaceutical... ...looking for a Senior Director, Regulatory Affairs, Global Regulatory... ...clinical, nonclinical, CMC, safety, commercial,... ...objectives of major global submissions and Health Authority... ...This is a fully remote role. It can be performed...Remote workFull timeLocal areaFlexible hours$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This... ...strategies. Experience with regulatory submissions and health authority interactions for...Full timeTemporary workWork at officeLocal areaFlexible hours$177.4k - $238.96k
...Position OverviewImmunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across... ...ensure adherence to accelerated regulatory submission schedules. Reporting into the Senior Director...Flexible hours- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's development... ...-quality CMC content for regulatory submissions, provide phase-appropriate...Work at officeFlexible hours
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