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...
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...
Represent regulatory affairs in project team meetings and provide regulatory guidance to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues. The Regulatory Affairs Manager will be responsible for independently compiling and main...
Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures requi...
The Regulatory Affairs Manager will be responsible for ensuring compliance with all regulatory standards and guidelines, leading the preparation and submission of regulatory documents including CMC modules, and overseeing the development of generics including Risk Evaluation and Mitigation Strategie...
Internal Job Title: Regulatory Affairs Associate II. Position requires a Bachelor's degree in a science or chemistry-related field, coursework or certification in Cosmetic or Drug Regulatory Affairs. Canada Chemical regulatory oversight and review. ...
Support the development of regulatory strategy and update strategy based upon regulatory changes. Manage the regulatory activities for multiple projects simultaneously and respond readily to changing events and priorities. Ensure timely completion, accuracy, and quality of all regulatory and submiss...
Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training. Responsible for any additional duties or assignments as directed by Manager of Regulatory...
We are looking for an entry-level Regulatory Registration Assistant to join our Research & Innovation (R&I) team. This position is a corporate desk job focused on supporting regulatory registration for global product launches. ...
Represent regulatory affairs in project team meetings and provide regulatory guidance to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues. The Regulatory Affairs Manager will be responsible for independently compiling and main...
The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on market products or those products in development. Assures that defined regulatory strategies defined are effectively implemented and mainta...
Hiring - Senior Regulatory Affairs Specialist. Assess applicable change requests for regulatory impact and follow-up on related regulatory action items. Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing US regulatory assessme...
Position Title: Senior Scientist I,Regulatory Affairs. We are seekinga Senior Scientist - Regulatory tojoin our Regulatory team inour Clark, NJ Researchfacility. This role is responsible for supportingthe Hair product team on regulatory compliance and regulatoryreporting/registration requirements. A...
As the Director, Regulatory Affairs – Advertising, Promotion and Regulatory Compliance you will be responsible for leading a group of US Regulatory Affairs professionals responsible for advertising and promotion, compliance, labeling and submission operations within US RA. Coordinate regulatory proc...
As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. ...
The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s). E...
The Director Advertising & Promotion, Regulatory Affairs provides strategic regulatory advice, risk assessment, and mitigation strategies to support the advertising and promotion of assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and co...
They engage in correspondence, meetings, and interactions with the FDA to address regulatory inquiries, respond to requests for additional information, and seek clarification on regulatory matters under the guidance of the Director, US Market Access. Analyzes and communicate the adequacy of proposed...
RegularScientific Affairs & Regulatory AffairsProduct Quality, Safety and Compliance. Scientist II will u execute the scientific affairs strategy for your respective categories and geographical area using your scientific and regulatory expertise. You advocate for our regulatory and scientific positi...
The Associate Director US Regulatory Affairs CMC is responsible for creation and implementation of CMC regulatory strategies to support the Bayer’s development and marketed product portfolios. Associate Director US Regulatory Affairs CMC. The primary responsibilities of this role, Associate Director...
Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. Assist the Manager of Regulatory Affairs during periodic quality reviews, regulatory updates, and annual GMP training. Responsible for facility registrations, renewals, and document submissions to regulatory ...
Keep abreast of regulatory changes in our markets, assessing and communicating impact to the Regulatory Affairs team and other internal stakeholders /. Sr Scientist, Regulatory Affairs. Administer regulatory affairs over the product lifecycle from pre-market concept, product development, registratio...
Prepare new and maintain existing regulatory files in accordance with regional requirements, including but not limited to document updates, management of regulatory information in databases, and navigating document control systems. Review regulatory content for completeness, accuracy, consistency, a...
The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for as...
Performs quality control, research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring that Good Clinical Practices (GCP) are adhered to and communicating protocol deviations appropriately per Standard Operating Procedures...