A company is looking for a Regulatory Consulting Associate responsible for preparing plan documents and providing regulatory compliance support. ...
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...
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...
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...
Chemistry or equivalent degree plus 10 years industry experience directly in Regulatory Affairs or in CMC and clinical regulatory or role with regulatory submission responsibilities. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturin...
Provide regulatory review and impact/implementation assessment of proposed Change Control records and manage the associated regulatory notifications. Serve as the primary liaison with internal stakeholders and external collaborators on regulatory responsibilities and ensure timely support of regulat...
This position will be responsible for supporting the maintenance of the Global Regulatory Affairs filing system and the Registration Tracking System (RTS) database. This individual will be key to the continued compliance of the regulatory and labeling documentation. Maintain the Global Regulatory Af...
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...
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...
Please look for associates who have background not just in Regulatory Affairs but also from engineering, quality, and manufacturing, who are willing to look for a career in Regulatory Affairs. ...
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...
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, 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...
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 ...
Provide regulatory review and impact/implementation assessment of proposed Change Control records and manage the associated regulatory notifications. Serve as the primary liaison with internal stakeholders and external collaborators on regulatory responsibilities and ensure timely support of regulat...
Develop regulatory processes including GSRA standard operating procedures, policies, guidelines and/or chassis in compliance with applicable regulatory requirements and drive core training and documentation on regulatory processes, and other applicable regulatory operations requirements to maintain ...
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 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 ...
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....
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 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 ...
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...
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...
Author and/or review high quality CMC sections for global regulatory submissions (IND/CTA, and BLA/MAA), applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines. Provide regulatory review and impact/implementation assessment of proposed Change Control records and ...
She/he utilizes in-depth knowledge of global regulatory submission requirements and works collaboratively within Regulatory Affairs and other cross-functional departments in providing guidance towards achieving department application filing objectives, identifying areas of concern that are impacting...