Manager, Regulatory Affairs Compliance and Planning professional will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget. Manager, Regulatory Affairs Compliance and Planning professionalis responsible for driving implementati...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. A minimum of 4 years in IV...
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures r...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...
My client is a multinational CDMO looking for a Regulatory Affairs Manager to work with the FDA and their client sites to manufacture generic APIs, drug products, and certain med devices. Looking for a unique approach to Regulatory Affairs? Want to push boundaries and bring life-saving medicine to t...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
With minimal direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product l...
DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publis...
A rapidly growing biotech/medical device client of X4 Life Sciences is looking for 2 Regulatory Affairs Managers to join their fast-paced organization. One manager (Major Markets) will focus on EU, US and Canada regulations and the other manager (International Markets) will focus on meeting internat...
The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures r...
Regulatory Affairs Associate Manager, APAC Self Care-2407021602W. Regulatory Affairs Associate Manager, APAC Self Care. Representing Asia Pacific Regulatory Affairs in cross-functional Regional and Global teams. Collaborating with regulatory colleagues in APAC markets to drive business growth throug...
Manager, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. Advanc...
Job title: Senior Manager, US Advertising & Promotion, Global Regulatory Affairs. Under the direction of the Director, this individual will be responsible for providing US regulatory review and approval of promotional and other product and disease-related materials within the Medical Affairs and Com...
Responsibilities Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits ...
Manager, Regulatory Affairs Compliance and Planning professional will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget. Manager, Regulatory Affairs Compliance and Planning professional is responsible for driving implem...
The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide. A minimum of 4 years in IV...
The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for as...
Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning, authoring, compiling and submitting highest-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicab...
Responsibilities Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits ...
The Regulatory Affairs Project Manager is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; Working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory ...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
As the Senior Manager, Regulatory Affairs you will be responsible for the development and execution of US regulatory strategy for projects within an assigned Therapeutic Area (“TA”). Develop and execute US regulatory strategy, with oversight as needed, and in conjunction with Global Regulatory Lead ...
The Field Medical Cell Therapy Onboarding Manager is a member of a field-based team of scientists who function as an extension of the US Hematology Medical Affairs organization. This position will liaise internally and externally to provide cell therapy medical onboarding information and verificatio...
The Senior Manager, Regulatory Affairs will handle publishing and coordinating tasks for Global RA submission activities. Review and track the archiving of global eCTDs , paper submissions and Health Authority correspondences using Regulatory Affairs systems/tool. Publish, review, submission and arc...