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...
Global Regulatory Affairs Operation(Sr. This position belongs to Global regulatory affairs department, serving the global Market which encompasses China US, EU, AUS and others. This role requires a detail-oriented professional who can oversee all regulatory affairs and quality assurance activities, ...
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...
Manager of Regulatory Affairs Strategy to join their team. Serves as a liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. We are currently partnered with a growing biopharmaceutical company in need of a Manager/Sr. This role is...
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...
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 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...
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...
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...
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...
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 ...
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 ...
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...
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...
Senior Director, Global Regulatory Affairs Strategy. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with regulatory agencies, and being responsibl...
Ramboll is seeking a highly motivated Manager to lead projects and tasks primarily in regulatory compliance and land use permitting. Provide project strategy, oversight and direction for regulatory compliance, environmental permitting and land use projects. Conduct and prepare permitting alternative...
Responsibilities of the Project Manager/Senior Project Manager. The ideal candidate will have the opportunity to work on a variety of projects including due diligence Phase II Subsurface Investigations, Vapor Intrusion Investigations, Site/Remedial Investigations, and development of Remedial Action ...
Associate Director/Director, Regulatory Affairs (Oncology). They are looking for an Associate Director or Director of Regulatory Strategy to join their team. This role will be reporting into the VP of Regulatory Affairs and will be serving as the Lead for a US Phase III Oncology program. Serve as SM...
Trade Compliance Analyst to ensure adherence to import/export regulations for the US and Canada. If you're detail-oriented with a passion for trade compliance, we want to hear from you!. ...
The Director, Regulatory Affairs should have an advanced degree, preferably in the sciences, and have demonstrated application of regulatory expertise by at least 8+ years pharmaceutical industry experience. The Director, Regulatory Affairs is required to have excellent written and oral communicatio...
The Brands and Innovative Medicines Global Regulatory Affairs organization is seeking a Senior Director, Global Regulatory Portfolio Leader. The role will be a key member of the Global Regulatory Affairs Leadership Team, reporting directly to the VP/Head, Global Regulatory Affairs. Working with lead...
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...
The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidances, and company policies. Develop and maintain positive ra...
Korn Ferry has partnered with our client on their search for the role, General Manager (Sales & Distribution Operations). The General Manager has the responsibility for setting the direction of the business and has leadership accountability for all plans both strategic and tactical that ultimately r...