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...
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 Associate Director, Medical Writing (Regulatory) will collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US ...
The Senior Regulatory Associate role will be working with regulatory operations as well as regulatory affairs on submission preparation to global regulatory authorities. Specifically, this role will work closely with the Regulatory Operations Manager and the Regulatory Leads to support day-to-day ac...
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...
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...
Internal regulatory support for operation and control eg:Review and approval of Lonza Regulatory Intelligence Bulletin, Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of biological products and maintain transparency of ...
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...
Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research. Independently provide strategic guidance/input related to current regul...
The Associate Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-...
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 Associate Regulatory Affairs Manager is responsible for regulatory document develop...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
As an Associate Regulatory Counsel, you will join a Global team that provides subject matter expertise and engages with regulators, academics, and others to consider the role of competition law in the our changing economy, the development of new technology, and passage of new laws and regulations. ...
Medical Writing is a global, dynamic, and diverse team residing within Global Regulatory Affairs. We work collaboratively to advance the strategy and create high-quality documents for successful regulatory submissions, by bringing our passion for science, discovery, and innovative strategic thinking...
Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function wi...
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...
Help determine regulatory strategies for manufacturing changes and regulatory activities. 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. Degree in Regul...
Help determine regulatory strategies for manufacturing changes and regulatory activities. 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)...
Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products. Associate Director, Regulatory Affairs Advertising and Promotion. Regula...
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...
Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function wi...
Document management including uploading and tracking regulatory files, archival of regulatory correspondences and maintenance of regulatory submission log according to established procedures. Liaise with the Global regulatory lead and provide regulatory guidance for assigned projects, as applicable....
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...
Participates in preparing regulatory submissions under direction of a senior Regulatory Affairs Professional which require some interactions with other members in the Regulatory department for investigational and commercial products in line with US and ICH requirements, regional requirements and sci...