Regulatory Affairs Director Jobs in USA

We are seeking an Associate Regulatory Affairs for our North America business. The incumbent will be responsible for maintenance and tracking of regulatory documentation and information pertaining to life cycle management activities; assisting in review of CMC documents for supplements ANDAs NDAs DM...

The Manager Labeling Regulatory Affairs Strategic Labeling develops and maintains US/EU package inserts and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. The Manager leads discussions to ensure global consistency of labeling an...

The R&D Regulatory Affairs Finance team supports the leadership in strategic planning and execution of both current and long-term goals around resource and budget management. This position is responsible for financial planning and analysis related to Plan Update LRP (Long Range Plan) and Latest Best...

Are you ready to steer US promotional regulatory strategy in a way that accelerates responsible growth and earns patient and prescriber trust This role translates science into clear compliant communication across healthcare professionals consumers and payersso that what we say is as strong as the me...

Please note that this position can be based in San Diego CA or Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.Position SummaryThe Associate Director Regulatory CMC is responsible for contributing to/assisting with the development and implem...

DescriptionSummer Quality/Regulatory Affairs Summer Internship Program offers students the opportunity to gain experience in Public Health Reporting by laboratories to support disease surveillance outbreak detection population health monitoring and regulatory and mandated reporting.This is an Onsite...

Primary Function of PositionThe Regulatory Affairs Manager will lead the strategy and execution of regulatory submissions for drug products ensuring compliance with FDA and international standards. This includes chemistry manufacturing and controls (CMC) lifecycle from early-stage development throug...

THE POSITION: The Director Global Regulatory Affairs collaborates with clients project team members and key decision makers to gain a complete understanding of a product and transforms that knowledge into an actionable regulatory strategy. As a Director Global Regulatory Affairs you are also respons...

The Senior Specialist Regulatory Affairs Business Operations manages low-to-medium complexity business processes and project management support for the Regulatory Affairs function. With support from management and by fostering efficiency through data analysis and process management this role is inte...

OverviewPhiladelphia Gas Works Looking for a challenge and ready to light up your career The Philadelphia Gas Works (PGW) is the largest municipally-owned gas utility in the nation supplying gas service in the City of Philadelphia to over 500000 customers. From its humble beginnings in 1836 PGW has...

Primary Function of PositionThis position will partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams make sure the companys regulatory affairs activities are conducted in accordance with company policies and in complianc...

Primary Function of PositionThis position will partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams make sure the companys regulatory affairs activities are conducted in accordance with company policies and in complianc...

Do you have knowledge in Regulatory Affairs Strategy and Policy underpinned with experience transformingDigitalprocesses with AI and automationIf you want to work on innovative projects of high importance for our Respiratory and Immunology(R&I)portfolio then AstraZeneca is the place for aspiration...

Primary Function of PositionThis position will partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams make sure the companys regulatory affairs activities are conducted in accordance with company policies and in complianc...

Primary Function of PositionThis position will partner with the in-country RA team as well as the Product Localization Engineering (PLE) and other cross-functional supporting teams make sure the companys regulatory affairs activities are conducted in accordance with company policies and in complianc...

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially di...

The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions (i.e. FDA 510(k) submissions Health Canada Device License Applications). This role also supports post-market regulatory compliance activities. Rol...

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially di...

The Regulatory Affairs Engineer role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially dist...

ViiV Healthcare is a global specialty HIV company the only one that is 100% focused on researching and delivering new medicines for people living with and at risk of HIV. ViiV is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by...