Regulatory Submissions Jobs

AbbVie seeks a detail-oriented Paralegal to manage contracts, support regulatory submissions, and coordinate legal activities for the R&D Innovation and Global Alliances team in North Chicago.

Support AbbVie's regulatory submissions as a Medical Writing Coordinator/Publisher II by formatting, publishing, and coordinating CSR appendices and maintaining RIMS/document standards in a remote role.

Lead regulatory strategy and submissions for multiple virology programs at Gilead, acting as regional or global regulatory lead and interfacing with health authorities.

Regulatory Affairs Specialist I needed to support product registrations, prepare regulatory submissions, and ensure compliance with US and international medical device regulations at BD's Covington site.

Experienced regulatory affairs professional needed to lead global regulatory strategy, submissions, and agency interactions for medical device products at BD’s Salt Lake City site.

Becton, Dickinson and Company is hiring an entry-level Regulatory Affairs Associate to support medical device product lifecycle activities, regulatory submissions, and compliance efforts at its Tempe headquarters.

Lead the global regulatory strategy and submissions for a growing clinical-stage biotech developing innovative autoimmune therapies, serving as the regulatory lead for the MMN program (remote, U.S.).

Lead and manage statistical programming across clinical studies, overseeing FSP delivery and driving quality, compliance, and process improvements for a biopharmaceutical-focused team.

Terremoto Biosciences is hiring an experienced Director/Sr. Director to lead analytical development and QC for small molecule programs, overseeing internal activities and CDMO partnerships in South San Francisco.

A paid summer Regulatory Affairs internship at Philips San Diego providing practical experience with medical device regulatory submissions, documentation, and compliance.

Lead statistical strategy and execution for clinical development and lifecycle management at AbbVie, providing expert design, analysis and regulatory support for assigned projects.

FUJIFILM Sonosite is hiring a Regulatory Affairs Associate to oversee international product registrations and support global regulatory compliance for its point-of-care ultrasound product portfolio.

BD Life Sciences is hiring a Senior Regulatory Affairs Specialist in Milpitas, CA to lead preparation and management of global regulatory submissions for IVD and RUO products.

Insulet seeks a Project Manager, Regulatory Operations to lead regulatory intelligence coordination, document control, and cross-functional project management supporting product compliance and market authorizations.

Experienced labelling professional needed to lead global CCDS/USPI/SmPC strategy and cross‑functional labelling activities for a global regulatory team on a remote contract basis.

Lead and coach Global Project Team Heads to optimize Sanofi's immunology portfolio, drive program execution, and contribute to TA strategy and development.

Experienced regulatory leader sought to head the Regulatory Affairs function at e.l.f. Beauty, guiding global compliance and building a high-performing team across cosmetics, skincare and OTC products.

Moderna seeks a Senior Manager, Analytical Science & Technology (AS&T) to lead analytical method qualification, validation, transfer, and lifecycle strategy for late‑phase and commercial CMC programs at the Norwood, MA site.

Senior scientific leader to head observational research for obesity at Amgen, delivering RWE and study designs to support development, regulatory and commercial goals.

SDC is hiring a Director of Biostatistics to lead statistical operations, oversee clinical trial analyses and regulatory submissions, and mentor a growing team within a technology-enabled CRO.

Lead program-level vaccine clinical development strategy and execution, managing a small team and collaborating across functions to deliver high-quality global clinical trials.

Experienced CMC biologics program leader needed to drive process development, regulatory strategy, and cross-functional delivery for AbbVie's biologics pipeline.

Rho is hiring a Vice President, Global Biometrics to lead and scale biostatistics, data standards, and statistical programming worldwide while advancing regulatory and methodological excellence.

Lead global regulatory strategy and submissions for trauma and extremities orthopedic devices at Stryker, ensuring compliance and market access across regions.

AbbVie is seeking an experienced Senior Manager, Statistics to lead design, analysis and reporting for clinical and other scientific programs in a hybrid role based in North Chicago, IL.

An experienced analytical scientist is sought to lead method development, stability and impurity control programs at Eurofins’ Groton pharmaceutical site, driving GMP-compliant analytical strategies and regulatory deliverables.

Senior biostatistics leader needed to drive PK/PD strategy, modeling, and regulatory support across clinical programs for a US-based biopharma partner (remote).

Experienced regulatory leader needed to drive US and Canada regulatory strategy, manage FDA interactions, and oversee submissions for assigned products in a hybrid role based in North Chicago, IL.