Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in supp. ...
Regulatory Affairs Associate, CMC. Sr Associate, Regulatory Affairs, CMC. Represent Regulatory Affairs (RA) CMC on product development and life-cycle management teams to identify the critical issues, negotiate, influence, and provide strategic advice to peers in Pharmaceutical Development and Manufa...
Document management including uploading and tracking regulatory files, archival of regulatory correspondences and maintenance of regulatory submission log according to established procedures. The individual will represent Regulatory Affairs and work closely with cross-functional teams and external p...
Together with the Regulatory Affairs team and in close collaboration with other departments, the Associate Director / Director, Regulatory Affairs will take a hands-on approach to developing and implementing regulatory strategies for our development programs in rare diseases. A degree in a life scie...
Associate Director, Regulatory Affairs Advertising and Promotion. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Significant experience contributing t...
The Associate Regulatory Affairs Manager will be responsible for completing the regulatory work for the Health and Biosciences business and applicable joint ventures, with a focus on food applications, for the U. Associate Regulatory Affairs Manager. Update Registration List to communicate the statu...
Regulatory Affairs Associate, CMC. Represent Regulatory Affairs (RA) CMC on product development and life-cycle management teams to identify critical issues, negotiate, influence, and provide strategic advice to peers in Pharmaceutical Development and Manufacturing, RA, and Regulatory Operations. Mas...
Together with the Regulatory Affairs team and in close collaboration with other departments, the Associate Director / Director, Regulatory Affairs will take a hands-on approach to developing and implementing regulatory strategies for our development programs in rare diseases. A degree in a life scie...
The Associate Regulatory Affairs Manager will be responsible for completing the regulatory work for the Health and Biosciences business and applicable joint ventures, with a focus on food applications, for the U. The The Associate Regulatory Affairs Manager is responsible for regulatory document dev...
The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding o...
The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities. Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary ...
Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required. Job Title: CMC Regulatory Affairs, Data Entry Contractor Position. Work is performed under the general supervision of more senior Regulatory Affairs CMC professionals. Top 3 Nice t...
Regulatory Affairs Associate I. A Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulatory activities. Coordinate and track workflows for regulatory submissions. ...
About the role:Allogene is seeking an Associate Director, CMC Regulatory Affairs to provide support for products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain teams. Reporting to the Head of Regulatory Affairs, th...
Associate Director, Regulatory Affairs Advertising and Promotion. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Significant experience contributing t...
Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulat...
A Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing chang...
A Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with - years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulator...
Assist in preparing product dossiers for regulatory submission to regulatory. Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in support of maintenance and compliance requirements as well as development projects. You will be the primary contact and provid...
Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulatory activities. Coordinate and track workflows for regulatory submissions. Ensure regulatory submissions meet global st...
The Associate Director, Analytical Regulatory Science, collaborates with product. By balancing analytical knowledge and evolving regulatory expectations with manufacturing and analytical flexibility the incumbent will support “right first time” global approvals for CMC control strategies and maintai...
Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Significant experience contributing to the development of commercial regulatory or related strategies, ...
Associate Director, Clinical Regulatory Affairs . This successful candidate will be proficient in the principles of scientific writing and will work cross?functionally, advising the team on regulatory expectations for document co...
The Head of CMC Regulatory Affairs / Associate Director will lead the site Regulatory Affairs function and customer related RA CMC compliance activities. Internal regulatory support for operation and control eg:Review and approval of Lonza Regulatory Intelligence Bulletin, Interpretation of EU, US a...
Degree in Regulatory Affairs with a minimum of months of regulatory experience (internship) is required. Degree in Regulatory Affairs with a minimum of months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulatory activities. ...