Facilitate preparation and completion of documentation to support electronic or paper submissions (e.g., IND, CTA, NDA) to FDA and to ex-US regulatory agencies in collaboration with team members from other functional areas and more...
Biotest Pharmaceuticals Corporation
The Director-Regulatory Affairs, supervises departmental operations, developing staff, assigning and reviewing development projects and needs for facilities, to insure attaining corporate goals. Serve as liaison/representative for company's...
Neurocrine Biosciences, Inc.
The Regulatory Director will influence organizational decisions that involve multiple groups and/or locations.
Essential Duties and Responsibilities (include but are not limited to)
Implement and Manage all Regulatory activities required to bring...
Revance Therapeutics, Inc.
This position leads the execution, maintenance and monitoring of Regulatory submissions in compliance with approved procedures. This position recommends regulatory strategy and manages global regulatory submissions for development...
The Associate Director, under the direction of the Head of Product Communications within Commercial Regulatory Affairs, will be responsible for regulatory strategy and operational leadership in the area of product and disease state communication for...
Peregrine Pharmaceuticals, Inc.
Peregrine Pharmaceuticals, on the list of Deloitte & Touche’s 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on medical writing expertise in the pharmaceutical industry to become part of our...
This candidate will be a champion for customer quality, lead the implementation of an ISO 9001 Quality Management System, and be responsible for quality management, quality assurance, and regulatory affairs for the organization.
• Develop an overall...
General Job Description:
The Manager/Director, Quality Assurance and Regulatory Affairs is primarily responsible for development, implementation and maintenance of quality assurance systems and activities; and manages regulatory affairs functions...
Management and leadership of the global regulatory development activities for assigned product(s). In this role the Director is responsible for representing Regulatory Affairs at core team and sub-team meetings and other scientific...
Meridian Bioscience Inc.
The Regulatory Affairs and Design Assurance professional, Level I (RADA I) will be responsible for supporting Meridian’s Product Realization Process and ensuring products are designed and manufactured in a manner consistent with applicable Regulatory...