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 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...
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...
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...
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...
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 ...
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...
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/Associate Director of Regulatory Affairs Strategy to join their team. This role is responsible for developing, implementing, and leading short/long term global regulatory strategies that support the success of their pharmaceutical products. ...
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...
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...
Work with CMC cross-functional teams and Regulatory Affairs teams. PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with + years in the pharmaceutical industry, preferably with + years CMC regulatory experience, Sterile Injectable experience preferred. Participate i...
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/Associate Director, Regulatory Affairs Strategist. Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development...
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...
Manage project schedules and scope, assist in creating the project budget, oversee deliverables for quality and assist in staffing projects. Lead small project management teams assisting in project managing components of a larger technological program. Identify and mitigate risk through status repor...
The Operations Manager plays a key role at the. Please include “Operations Manager” in the subject line. The individual in this position will develop and maintain systems to guide the organization’s business operations, meet basic financial management and compliance requirements, and address evolvin...
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory st...
A recognized private organization in New Jersey is currently seeking a new Project Manager to join their growing team. Identify, prioritize and sequence the project goals; identify key stakeholders who will need to be engaged to assess impact of contract proposals (systems, processes, practices, exi...
The Senior Regulatory Operations Specialist position is an integral part of MRM for Health and the Regulatory Operations capability. Regulatory Operations is accountable and responsible for the preparation, review, and submission of regulatory packages to Client Medical, Legal and Regulatory (MLR) g...
In this role, you will be responsible for project management activities for a Workday HCM project which requires knowledge and understanding of the HCM modules. Experience in leading and execution of testing in all the cycles of the project. ...