Regulatory Manager jobs in Columbia, MD

Head of Regulatory Compliance & Senior Risk Manager Join to apply for the Head of Regulatory Compliance & Senior Risk Manager role at Computershare U.S. Location Location: New York NY, Columbia MD, Jersey City NJ, Saint Paul MN, Canton MA (Hybrid) In this position, you’ll be based in one of our New York, Columbia, Jersey City, Saint Paul or Canton offices for a minimum of three days a week,...

Join to apply for the Senior Regulatory Affairs Manager role at Katalyst CRO .2 days ago Be among the first 25 applicants.ResponsibilitiesSupport the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions.Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and...

About the JobMedStar Health's strong commitment to the highest quality & safety for our patients is led by the system quality & safety team together with leaders from all MedStar Health entities. Over the last ten years, the organization has developed and executed a unique approach to quality and safety which supports the organization's vision to be the trusted leader in caring for people and...

Responsibilities: Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Partner with RA CMC Project Leads and develop module content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections. Skills for running review meetings for submission documents. Understand CMC expectations...

Posted Thursday, November 13, 2025 at 5:00 AM About The Chefs' Warehouse The Chefs' Warehouse, Inc. (http://www.chefswarehouse.com ) combines exceptional quality and brand building with broadline food service distribution for more than 40 years. With Protein, Specialty, Produce, and Broadline offerings, we service the most discerning chefs in a hybrid approach of convenience and superior...

Overview McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make...

Partners with internal clients to implement strategic compliance initiatives for T. Rowe Prices proprietary and subadvised 40 Act products focused on delivering measurable business results and coordinating compliance activities across multiple depar Compliance, Manager, Regulatory, Advisor, Business Partner, Business Services, Program

Global Product Regulatory Compliance Senior Program Manager Towson, MD - Hybrid. Come build your career. It takes great people to achieve greatness. People with a sense of purpose and integrity. People with a relentless pursuit of excellence. Peopl Program Manager, Compliance, Product, Manager, Senior, Regulatory, Manufacturing, Technology

When you come to the University of Maryland St. Joseph Medical Center, you’re coming to more than simply a beautiful 37-acre, 218-bed suburban Baltimore, Maryland campus. Joining our team of healthcare professionals means you’ll be contributing to a locally and nationally recognized institution. Joseph has been recognized by The Leapfrog Group as a grade ‘A’ hospital and by U.News & World Report...

Job SummaryThe Senior Manager, CMC is responsible for managing the regulatory aspects of projects/products including the preparation and submission of correspondence and applications to regulatory agencies.Essential Duties & ResponsibilitiesIdentifies, obtains, compiles and reviews regulatory documents concerning CMC-related issues that are needed for FDA submissions including IND, NDA, NDA...

A leading pharmaceutical company seeks a Senior Manager Regulatory Affairs CMC in Rockville, Maryland. This role entails overseeing regulatory aspects of projects, preparing and submitting applications to regulatory agencies, and ensuring compliance with FDA regulations. Candidates should hold a Ph.D. or relevant Master's/Bachelor's with significant experience in regulatory affairs. The position...

Job SummarySenior Manager, Regulatory Affairs delivers Regulatory Affairs and compliance guidance and strategic input as a subject matter expert in Biosimilar Development and Life Cycle Management to find smart solutions for optimized submission, submission rollout, and maintenance. Autonomously drive the regulatory strategy. Manage cross functional activities for dossier preparation and...

Overview Site Name: USA - Pennsylvania - Upper Providence, Baar Onyx, Belgium-Wavre, GSK HQ, Poznan Grunwaldzka, Rockville Biopharm, USA - Massachusetts - Waltham, USA - North Carolina - Durham, WarePosted Date: Oct 21 2025Job Purpose Responsible for the CMC regulatory activities in the commercial lifecycle management of GSK products.Key Responsibilities Responsible for the global CMC regulatory...

Best Buddies International is a nonprofit 501(c)(3) organization dedicated to establishing a global volunteer movement that creates opportunities for one-to-one friendships, integrated employment, leadership development, inclusive living, and family support for individuals with intellectual and developmental disabilities (IDD). Best Buddies is the largest organization dedicated to ending the...

A leading pharmaceutical company in Gaithersburg, MD, is seeking a Regulatory Affairs Director to develop global strategies and manage regulatory submissions for complex products. The ideal candidate will have over 8 years of experience in regulatory roles, strong knowledge of drug development, and excellent interpersonal skills. This role offers a competitive salary, and the company promotes a...

Join to apply for the Senior Manager Regulatory Affairs CMC role at Supernus Pharmaceuticals, Inc.1 day ago Be among the first 25 applicantsJoin to apply for the Senior Manager Regulatory Affairs CMC role at Supernus Pharmaceuticals, Inc.Get AI-powered advice on this job and more exclusive features.Job SummaryThe Senior Manager, CMC is responsible for managing the regulatory aspects of...

Join to apply for the CMC Regulatory Affairs Manager role at Katalyst CROLocation: Baltimore, MD | Salary: $125,000.00-$150,000.00Overview Role focused on leading CMC regulatory activities across global regulatory filings, ensuring accuracy, compliance, and alignment with regulatory strategies throughout the product lifecycle.Responsibilities Lead the preparation, review, and submission of CMC...

A leading healthcare company is seeking a Regulatory Affairs Manager to join their team. This remote role focuses on conducting comprehensive due diligence assessments for strategic account pharmacies, analyzing data, and collaborating cross-functionally. Ideal candidates will have a strong background in data analytics and compliance within the healthcare sector. The position requires strong...

Responsibilities: Lead the preparation, review, and submission of CMC sections of regulatory filings (, INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines. Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including...

Responsibilities: Perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry of instrument hardware and software. Conduct reviews of product and...