The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
Keeps current with latest Health Authority guidelines and provides Regulatory advice to members within Regulatory, and various associated departments within the Company. More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs. Responsible for leadin...
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
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 individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
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...
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 Director, 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. The...
Senior Director - Regulatory Affairs. Provide responses to regulatory agencies regarding clinical research or regulatory application issues. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. This role is resp...
The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. This po...
The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required. The RA Associate Director, Labeling will be ove...
Keeps current with latest Health Authority guidelines and provides Regulatory advice to members within Regulatory, and various associated departments within the Company. More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs. Responsible for leadin...
Director, US Regulatory Affairs Strategy page is loaded. Director, US Regulatory Affairs Strategy. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that ...
The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group. Experience with document man...
The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. Utilize regulatory expertise and knowledge of regula...
Education/Certification Requirements: * College degree in life science or health related or pharmaceutical field, or the equivalent Knowledge, Skills, and Abilities: * 9-11 years of experience in US Regulatory Affairs in development, life cycle and post marketing regulatory ...
Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA’s Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulator...
As the Associate Director, Regulatory Affairs you will be responsible for leading the development and execution of US regulatory strategy for projects within an assigned Therapeutic Area (“TA”). Lead the development and execution of US regulatory strategy in conjunction with Global Regulatory Lead (...
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. Report to Senior Director, Regulator...
The Director, 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. T...
Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs**+ Location: Cambridge, MA or Bridgewater, NJ**About the job**The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). As the RC Regulatory Affairs representat...
The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group. Ability to interpret Regulat...
Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDAs Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other 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...