Regulatory Affairs Generalist - Remote & Global Submissions
PAREXEL
Parexel is seeking a Regulatory Affairs Consultant - Generalist to provide end-to-end regulatory support for strategic pharmaceutical partnerships. You will work across IND and NDA submissions, regulatory intelligence, and lifecycle maintenance, coordinating with clinical, CMC, safety, and QA teams to ensure timely, high-quality deliverables. The role emphasizes strong regulatory writing, submission management, and cross-functional collaboration within a fast-paced, global environment. #J-18808-Ljbffr
$145k - $185k
...highly motivated Senior Manager for Regulatory Affairs Operations. This role involves overseeing regulatory submissions and managing compliance with global standards. Candidates should have a... .... The position allows for remote work or requires being based in Boston...Remote work- ...Carlsbad, CA, is seeking an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds.... ...timely approvals. The candidate will lead complex submissions, oversee post-approval changes, and maintain...Remote work
- ...Angitia Biopharmaceuticals seeks a Director of Global Regulatory Affairs to drive regulatory strategy for development programs, coordinating... ...safety, statistics, and operations. You will lead global submissions and health authority interactions, guiding programs through...Remote work
- ...Productiv Team is seeking an HR Generalist to provide operational HR support for a global, distributed team across NA, Europe, LATAM, and India. The role focuses... ...in a virtual environment. You will thrive in a remote, agile setup and manage priorities effectively. The...Remote work
- ...Lab is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution... ...‑functional teams to prepare INDs and submissions, respond to health authorities, and... ...the VP, Regulatory Affairs and is based remote. This senior regulatory role requires...Remote work
- ...regenerates life in depleted soils globally with naturally occurring,... ...Summary: The Global Regulatory Affairs Lead is responsible for... ...includingdocumentation of submissions, official communications, and... ...Location: Home-based / Remote (USA-based preferred for proximity...Remote workLocal areaWork from homeShift work
- ...Northeastern University invites applications for a two-year Global Regulatory Affairs fellowship, conducted remotely in partnership with Dompé. The Pharm.D. graduate... ...training in global drug development, IND/CTA/NDA submissions, labeling, and health authority interactions with...Remote work
- ...Job Title: Global Regulatory Labelling Specialist Location: Deerfield, IL... ...days onsite required/2 days remote) Duration: 12 months... ...Pharmacovigilance (PV), Regulatory Affairs Labeling Team and Global... ...for improved safety variation submission process and related system changes...Remote workFull time
- ...Cardinal Health is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for international... ...and U.S. kitting activities. You will prepare submissions, maintain registrations, and coordinate with global teams to meet FDA and EU requirements. This...Remote work
$235k - $280k
...Job Title: Senior Director, Global Regulatory Affairs Reports to (Title): VP, Hengrui USA Location: Hybrid for NJ/MA candidates & Remote for out-of-state Job Summary: The... ...several upcoming NDA, BLA, and MAA submissions, providing an exceptional opportunity...Remote workFull timeMonday to Friday- ...Corporation’s Ortho Tech team seeks a Staff Regulatory Affairs Specialist, Mako and Enabling... ...across the product lifecycle. This remote role supports global development, market access, and... ...regulatory strategies, prepare FDA submissions, review technical documentation, and...Remote work
- ...is seeking a detail-oriented Regulatory Affairs Consultant to join their team... ...regulatory strategies for U.S. and global markets, preparing essential documentation for FDA submissions, and ensuring compliance with... ...industry. Both on-site and remote work options are available....Remote workContract work
- ...Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions, and FDA interactions. This role oversees US and international submissions and coordinates with global sites to ensure...Remote work
- ...Pharmaceuticals, Inc. seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for CMC across the product pipeline... ...functional teams and external partners to deliver compliant submissions on aggressive timelines. The role requires deep...Remote workWorldwide
- ...Company is seeking a Senior Vice President, Head of Global Regulatory Affairs to lead regulatory strategy across global submissions for late-stage programs and post-approval lifecycle management. The role is remote in the USA and reports to the Chief Medical Officer....Remote work
- ...NewAmsterdam Pharma is seeking a Director of Global Regulatory Affairs for a remote role in the USA. You will lead regulatory strategy, submissions, and lifecycle management across clinical programs, coordinating with internal teams and external vendors to ensure timely...Remote work
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...Remote work
$180k - $230k
...Position: Director, Global Regulatory Affairs Department: Development - Regulatory Affairs Location: U.S (Remote) with up to 20% domestic travel Reports To: Executive... ...oversight and direction of major regulatory submissions, including INDs, CTAs, amendments, and...Remote workFull timeFor contractorsWork from homeOverseas- ...County IL area seeks a Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada to lead... ...coordinate FDA interactions, prepare submissions, and ensure timely responses to authorities... ...schedule (3 days in office, 2 days remote) with a strong emphasis on collaboration...Remote workWork at office
- ...candidate, we can consider remote East Coast) or Copenhagen, Denmark... ...Reporting to : VP, Regulatory Affairs & Quality About Hemab... ...Affairs, you'll shape and deliver global regulatory strategy for Hemab... ...for high-quality regulatory submissions and approvals, working with...Remote work
$153.6k - $241.34k
...Associate Director, Global Regulatory Affairs – GI & Inflammation Apply for the role at TakedaPharmaceutical... ...meetings. Accountable for all US FDA submissions related to assigned projects. Oversee... ...accordance with Takeda’s Hybrid and Remote Work policy. Compensation and...Remote workFull timeTemporary work- ...Redwood City, CA - Remote Role Job Summary:... ...development, and oversight of Global Patient Safety... ...timely and compliant submission of ICSSRs, expedited safety... ...and country-specific regulatory requirements and timelines... ...Safety, Regulatory Affairs, Clinical Operations,...Remote work
$284k - $302k
San Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide strategic regulatory... ...Trial Regulation (CTR) and CTA submissions.Serve as the primary... ...preferred in San Diego office. Remote permitted upon approval, with...Remote workFull timeSummer workWork at officeRelocationRelocation packageShift work- ...Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic and operational leadership for global regulatory activities spanning development to... ...oral solid dosage forms. The role leads CMC submissions (INDs, NDAs), serves as primary liaison with...Remote job
$138.75k - $231.25k
...Global Regulatory Affairs Manager, Oncology We create a place where people can grow, be their best,... ...to find the optimal balance between remote and in-office work. Discover more about... ...Plan Support interactions, reviews, and submissions with regional/local regulatory...Remote workWork at officeLocal area$154.4k - $242.55k
...to teams for the delivery of global regulatory strategies to support... ...execution of required maintenance submissions/notifications to ensure ongoing... ...the Global Regulatory Affairs (GRA) function in senior level... ...tailored communicationLocation: Remote within the USTakeda...Remote workMinimum wageLocal area- ...technology company located in Austin, Texas, is seeking an HR Generalist to oversee the day-to-day operations of the HR function. This role... ....S. employment practices, and excellent communication skills. Note that remote work options are not available. #J-18808-Ljbffr AvrideRemote work
$200.68k - $215.27k
...Cambridge, MAPOSITION: Senior Manager, Global Regulatory Affairs, Marketed ProductsPOSITION... ...vendors to ensure global regulatory submissions are provided to local company affiliates... ...integrated regulatory strategy. Up to 75% remote work is allowed. Up to 30% domestic travel...Remote workMinimum wageFull timeWork at officeLocal area$249.1k - $327k
...to hear from you.The Senior Director, Global Regulatory Affairs, Neurology will identify and... ...and objectives related to regulatory submissions and milestones, and clinical strategies... ...Wednesday, Thursday). We will consider remote candidates who are unable to regularly...Remote workFull timeTemporary work3 days per week$200.68k - $215.27k
...Cambridge, MA POSITION : Senior Manager, Global Regulatory Affairs, Marketed Products POSITION... ...vendors to ensure global regulatory submissions are provided to local company affiliates... ...integrated regulatory strategy. Up to 75% remote work is allowed. Up to 30% domestic...Remote workMinimum wageFull timeWork at officeLocal area
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Generalist - Remote & Global Submissions. Be the first to apply!
- clinical research regulatory Topeka, KS
- regulatory technician Topeka, KS
- regulatory Topeka, KS
- regulatory law Topeka, KS
- regulatory contract Topeka, KS
- food regulatory Topeka, KS
- remote recruitment consultant Topeka, KS
- benefits specialist remote Topeka, KS
- remote video game Topeka, KS
- remote typing work Topeka, KS



