Global Regulatory Operations Lead — Submissions & RIM
Jobtailor
Jobtailor in Cambridge, MA is seeking an experienced Regulatory Operations leader to oversee global regulatory submissions, publish in eCTD formats, and advance regulatory information management initiatives. You will coordinate cross-functional teams and external partners to ensure compliant, timely submissions and implement technology-driven improvements. Ideal candidate has 6-10 years in biotech/pharma regulatory operations, with FDA submission experience, Veeva RIM proficiency, and strong PM #J-18808-Ljbffr Jobtailor
- Parabilis Medicines is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions, information management, and publishing initiatives. You will drive Veeva RIM implementations and collaborate across Regulatory Affairs, Medical...Regulatory
- Vertex Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development and lifecycle programs... ...modern tooling like MS Project, Smartsheet, and Veeva RIM in a hybrid work environment. #J-18808-Ljbffr...Regulatory
$150k - $195k
...Therapeutics is seeking an Associate Director, Regulatory Project Manager to lead global regulatory affairs programs for rare... ...with Regulatory Leads, Regulatory Operations, and cross-functional teams to manage timelines, submissions, and health authority commitments. This...Regulatory- A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely delivery of regulatory documents. The ideal candidate...Regulatory
- ...seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... ...will influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal...Regulatory
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...Regulatory
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and commercializing... ...prepare regulatory submissions, interact with health... ...for supporting ongoing global clinical studies. #J-1...Regulatory
- ...Boston, MA seeks an experienced Regulatory CMC professional to drive high-... ...deliverables. You will support global filing strategies, coordinate... ...Regulatory Affairs, Technical Operations, and Quality, and ensure timely, compliant submissions across development, commercialization...Regulatory
- Beeline Medicines in Boston is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. This role... ...Affairs & Quality and will manage global regulatory submissions (IND/CTA/NDA/MAA) and interactions with health authorities...RegulatoryWorldwide
- Vertex Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle programs, including Pulmonary or Cell & Gene Therapy areas. You will partner with Global...Regulatory
$190.4k - $285.6k
## Director, Global Submission ManagementApplylocations: Boston... ...portfolio of global regulatory submissions across... ...regulatory strategies and operational objectives. This role... ...Major Submission Leads, Global Regulatory Strategy... ..., and Veeva RIM**Pay Range:**$190,400...RegulatorySummer workRemote workFlexible hours2 days per week- Tessera Therapeutics is seeking an experienced clinical operations leader to drive global clinical trials from start-up through close-out. You will... ..., ensuring compliance with ICH‑GCP guidelines and regulatory requirements. The role emphasizes risk management, timeline...Regulatory
- Merida Biosciences in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development programs. This hands-on role drives document readiness, eCTD publishing, cross-functional coordination...Regulatory
- A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs,...Regulatory
$154.4k - $242.55k
...The Associate Director, GCSC Operations Lead is responsible for... ...execution of GCSC activities globally. Under the direction of the... ...country investigational product regulatory requirements for delivery of... ...for Health Authority Submissions.Evaluate and propose system...RegulatoryMinimum wageContract workTemporary workLocal areaRemote work$120k - $202.5k
...Street’s Cyber Data & Analytics (CyberDNA) team is seeking a Global Operational Excellence Lead to establish world-class operational governance,... ...frameworks. This role will ensure operational stability, regulatory readiness, continuous improvement, and measurable business...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hoursShift work2 days per week- Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule. You will manage a portfolio of submissions,...Regulatory
$208.2k - $327.14k
Overview Head of Global Regulatory Affairs Operations, Compliance & Process Excellence (Senior Director) - role at BioSpace, as described in the job... ...Global RA business by overseeing all PDT regulatory submissions globally to ensure proper resourcing, planning and on-time...RegulatoryFull timeRemote workFlexible hours$70 - $75 per hour
...summary: Join a top-tier global pharma leader driving... ...this dynamic role, you will lead end-to-end labeling operations, bridge cross-functional... ...primary liaison between Regulatory/Labeling and Artwork/Change... ...delivery of USPI SPL submissions to the FDA. Support creation...RegulatoryHourly payContract workTemporary workWork experience placementLocal areaRemote workWorldwide$180k - $245k
...is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with... ...regulatory expectations.Lead the preparation, submission, and maintenance of regulatory applications, including...Regulatory- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop... ...will guide product teams and prepare CMC/Quality regulatory submissions with stakeholders to drive timely approvals. The role...Regulatory
$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development... ...over 7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from Cambridge,...Regulatory$212k - $333.19k
...Join us as a Senior Director, Global Program Lead- Neuroscience in our... ...to simultaneously driving regulatory approval as well as launch... ...Program Manager for activities operating budgets within the global program... ...large-scale Phase III/submission projects and global launch...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy... ...with cross-functional teams to ensure timely and quality submissions to the FDA and other agencies. Ideal candidates will have...Regulatory
- ...Senior Vice President, Global Regulatory Affairs About the Company A clinical-stage biotechnology... ...with a hands-on approach, capable of leading the team in interactions with global... ...regulatory documentation and submissions, providing strategic direction for regulatory...Regulatory
- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing... ...lead multiple teams and oversee all FDA submissions, driving strategic regulatory initiatives...Regulatory
$88.5k - $147.5k
...team, you will support vivarium operations by managing an assigned... ...Details As needed, Ops team lead may need to work on weekends.... ...for participation in Pfizer’s Global Performance Plan with a bonus... ...legal review and statutory or regulatory clarification, which Pfizer intends...RegulatoryPermanent employmentFull timeH1bWork at officeLocal areaRemote workVisa sponsorshipWork visaRelocation packageWeekend work- ...Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic... ...regulatory strategies to support global product development, particularly in immunology... ..., and the ability to manage regulatory submissions and work with health authorities such as...Regulatory
- Beeline Medicines in Boston is seeking a Director, Regulatory Strategy - Global Regulatory Lead to shape integrated global regulatory plans for early-stage... ..., CMC, Non‑Clinical Sciences, and Bioanalytics to drive IND/CTA and NDA/BLA submissions, #J-18808-Ljbffr BioSpaceRegulatory
- MBX Biosciences is seeking a Director of Regulatory Affairs to lead global regulatory strategies for its clinical stage programs, including INDs and... ...Clinical teams, manage FDA/EMA interactions, and oversee regulatory submissions and #J-18808-Ljbffr MBX Biosciences, Inc.Regulatory
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