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...

Job Title Responsibilities: Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Partner with RA CMC Project Leads and develop module 3 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...

Job Description Senior Manager, IFX, AIML, & Regulatory Risk - Enterprise Services Risk The Enterprise Services Risk (ESR) organization is expanding with a focus on attracting innovative, pioneering, collaborative, and highly skilled professionals. We operate at the forefront of risk management, providing support for novel and developing technologies, as well as critical business strategies....

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...

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...

A real estate development firm is seeking a Manager for Public Policy and Regulatory Affairs. The role involves monitoring regulatory dockets, researching energy policies, and providing analytical support in negotiations. Candidates should possess a Bachelor's degree in a relevant field and 3-5 years of experience in energy regulation. The position offers a competitive salary and extensive...

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...

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...

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...

Senior Manager, IFX, AIML, & Regulatory Risk - Enterprise Services Risk The Enterprise Services Risk (ESR) organization is expanding with a focus on attracting innovative, pioneering, collaborative, and highly skilled professionals. We operate at the forefront of risk management, providing support for novel and developing technologies, as well as critical business strategies. Diverse perspectives...

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...

Career Opportunities with NorthPoint Development LLC Current job opportunities are posted here as they become available. Manager - Public Policy, Regulatory Affairs This position is available in Kansas City, Missouri; St. Louis, Missouri; Cincinnati, Ohio; Philadelphia, Pennsylvania; Maryland/Washington, D.C. metro areas, or remote. NorthPoint is a real estate developer that has grown through...

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...

Senior Manager, IFX, AIML, & Regulatory Risk - Enterprise Services Risk The Enterprise Services Risk (ESR) organization is expanding with a focus on attracting innovative, pioneering, collaborative, and highly skilled professionals. We operate at the forefront of risk management, providing support for novel and developing technologies, as well as critical business strategies. Diverse perspectives...