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, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Clients s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment. Advanced...
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...
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...
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 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...
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 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...
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...
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 ...
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...
EisnerAmper is looking to hire a Senior Manager to join its Risk and Compliance Services practice as a dedicated member of the National Security Advisory services team. The Risk and Compliance Services National Security team drives value by delivering a range of risk advisory and compliance solution...
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...
Area Operations Manager - Aggregates. CSG Talent are currently looking for an Area Operations Manager within Aggregates for a leading US Construction Materials company. Promote a culture of continuous improvement within operations. Collaborate with the local Environmental, Health, and Safety Manager...
The manager will lead a dynamic team of 30-60 employees operating on multiple shifts. General Operations Management:. Take charge of the overall operations of the DC, including establishing and nurturing strong customer relationships. Direct subordinates to oversee all warehouse operations, encompas...
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...
Our client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. Launch the company's regulatory strategy having leadership over all regulatory activities. This role will lead the North America regulatory strategy and work extremely clos...
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...
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...
We are looking to hire a Corporate Strategy Programs Manager to support the execution of various strategic initiatives the Company has identified to allow the company to grow, become more efficient, and increase overall company performance. ...
The Enrollment or Compliance Representative provides a variety of support to Brokers assisting with all questions they may have. ...