Accountable for global/regional regulatory strategies for new and existing products in collaboration with the Global Regulatory Team (GRT). Manages and leads the preparation and review of regulatory applications, reports, and correspondence in a manner that ensures timeliness, accuracy, comprehensiv...
Senior Regulatory Affairs Specialist. A leading global medical device company is looking for a motivated and experienced individual to join their team as a Senior Regulatory Affairs Specialist at their facility in the greater Charlotte area. This role involves ensuring regulatory compliance and navi...
The new Global Regulatory Affairs Director is a critical hire to this organization leading PMA regulatory negotiations as the FDA point person as well as guiding clinical affairs, quality management, R&D, and all company team leaders toward successful pre-market approval. In collaboration with the V...
Insight Global is seeking a Regulatory Affairs Analyst to join one of our largest chemical clients in the country. ...
The AD, Regulatory Affairs is responsible for coordinating the regulatory activities for projects including new products and life cycle management. Provides guidance to product core teams to ensure that all regulatory submissions are planned, communicated, and executed per regulatory and business re...
Verona Pharma is currently recruiting a Senior Director, Regulatory Affairs to join our team, reporting to our Senior Vice President, Regulatory Affairs. In the role of Senior Director, Regulatory Affairs, you will be responsible for overseeing and directing regulatory activities for new and mature ...
The Director / Associate Director of Regulatory Affairs will be responsible for contributing to the development and overseeing the implementation of global regulatory strategies for assigned programs in alignment and in compliance with local and regional requirements, and company policies. This role...
This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. The Associate Director will b...
The Director, Regulatory Affairs is responsible for assisting with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environment...
Associate Director, US Regulatory Affairs, Advertising & Promotion - Permanent - Raleigh, NCProclinical is seeking an Associate Director, US Regulatory Affairs, Advertising & Promotion for a large global pharmaceutical company with locations in New Jersey, North Carolina and Massachusetts. The Assoc...
This goal must be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process and policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. Accountable to GRL and Global...
Associate Director, Regulatory Affairs, North America. Liaise with government and industry counterparts to track, analyze, and advise on proposed regulatory changes. ...
The Chiesi - Regulatory Affairs internship will be an immersive experience that will include exposure to several regulatory projects directly related to the development of drugs and biologics. Global Regulatory Affairs Project Coordination:. Maintenance of Global Rare Disease Regulatory Affairs trac...
The new Global Regulatory Affairs Director is a critical hire to this organization leading PMA regulatory negotiations as the FDA point person as well as guiding clinical affairs, quality management, R&D, and all company team leaders toward successful pre-market approval. In collaboration with t...
Regulatory Affairs and related non-clinical and clinical development. Experience with communicating the Regulatory strategy, issues, and risks in written and verbal format to Regulatory senior leadership team and other governing bodies within the Company. Excellent general communication skills, with...
The Senior Manager, Regulatory Affairs is an experienced leadership position with a deep understanding of global regulatory requirements, a strong track record in navigating complex regulatory landscapes, and the ability to collaborate across cross-functional teams. The Senior Manager of Regulatory ...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. Accountable to GRL (if one as...
Reporting to the Vice President of Global Regulatory Affairs (GRA), the Director of Chemical and Biological Regulatory Affairs will be responsible for setting the strategy for and leading the Chemical/Biological Regulatory Affairs team within the Global Regulatory Affairs organization. Assists in th...
Regulatory Affairs and related non-clinical and clinical development. Experience with communicating the Regulatory strategy, issues, and risks in written and verbal format to Regulatory senior leadership team and other governing bodies within the Company. Excellent general communication skills, with...
Regulatory Affairs and related non-clinical and clinical development. Experience with communicating the Regulatory strategy, issues, and risks in written and verbal format to Regulatory senior leadership team and other governing bodies within the Company. Excellent general communication skills, with...
Associate Director, Regulatory Affairs, North America. Bachelor’s degree in Accounting or Finance plus 5 years in-job experience or in Regulatory Affairs or Business Consulting. Liaise with government and industry counterparts to track, analyze, and advise on proposed regulatory changes. Present com...
At Thermo Fisher Scientific, the Regulatory Affairs function plays a vital role in ensuring compliance with the ever-evolving global regulations governing our industries. They collaborate closely with cross-functional teams, such as Research and Development, Quality Assurance, and Manufacturing, to ...
Quality/Risk Management Worldwide Regulatory Affairs. Regulatory Science from UNC, you will be prepared to play a critical role in the public or private sector to ensure that pharmaceutical products are safe and effective for human use. You'll acquire the professional savvy that this field demands a...
STEM related Bachelor's degree or 4+ years of experience in product compliance, quality, regulatory affairs, or engineering. The Regulatory Specialist is accountable for global product compliance through design consultation, manufacturing, and post market support. This role is responsible to carry o...
They will collaborate with Regulatory Affairs staff and contributing functional areas to assure adequate prioritization and scheduling of regulatory submissions. The Regulatory Operations Specialist will maintain familiarity with current regulatory submission standards and industry best practices. P...