Partner with the Reg Strategy Lead and other Regulatory SMEs to deliver regulatory deliverables. We are looking for an innovative, data-driven Associate Director/Director of Project Management. This multifaceted role will providing project management support for the regulatory submission deliverable...
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-...
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....
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...
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...
The Associate, working with the project team and regional regulatory leads in the US, EU and other countries, will support documentation for submission to regulatory authorities. Maintains knowledge of regulatory requirements and communicates changes in regulatory information to line manager and reg...
Our client is in search of candidates who demonstrate a keen interest and enthusiasm for tackling the intricate regulatory and policy challenges within the Medicaid program. This includes assisting with transaction structuring and negotiation, providing strategic counsel on regulatory and compliance...
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. Liaise with the Global regulatory lead and provide regulatory guidance for assigned projects, as applicable....
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...
Our client is in search of candidates who demonstrate a keen interest and enthusiasm for tackling the intricate regulatory and policy challenges within the Medicaid program. This includes assisting with transaction structuring and negotiation, providing strategic counsel on regulatory and compliance...
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 ...
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-...
Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar. Review clinical site regulatory documents to provide Regulatory approval to ship investigational product. Assist Project Team Regulatory...
Our firm is seeking a highly qualified associate with two to four years of health care regulatory experience to join our growing team. Our health care transactions and regulatory team assists with the structuring and negotiation of transactions, provides strategic advice on regulatory and compliance...
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 ...
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...
As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Associate Director Regulatory Affairs – A...
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...
This role reports to the Senior Director of Regulatory Compliance. Research and advise on regulatory compliance issues that impact Lyft’s Operations, Marketing, Finance and Product teams. Communicate regulatory compliance requirements and offer guidance to other teams including Communications, Produ...
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...
The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop regulatory submission strategy, and provide executive management with regulatory metrics/information. Associate Director Regulatory Affairs – US New ...
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...
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...