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...
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...
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...
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...
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. ...
CMC Regulatory Affairs Manager. Minimum 5 years of Regulatory Affairs experience in the industry. Provide regulatory assessments of CMC change controls. Regulatory support for state and FDA inspections. ...
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. ...
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. ...
Senior Associate , Regulatory Affairs - 2407025090W. Senior Associate, Regulatory Affairs, Dietary Supplements. This position reports to the Director, Regulatory Affairs and is based in Skillman. ...
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. ...
Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering therapeutic area strategy, corporate goals, and regional regulatory requirements/precedence. In collaboration with Regulatory Intellig...
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...
Assist the Manager during periodic regulatory reviews, regulatory updates, and annual GMP training. Assist the Manager during cGMP, Environmental, and Regulatory audits. Generate Raw Material Regulatory statement: Origin Statement, Clean List, Sephora, Ulta, Cruelty Free statement, Heavy metal state...
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...
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 ...
Job Title: CMC Regulatory affairs / Animal Health Care. Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields. Knowledge on relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications. Lead develop...
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. ...
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...
Perform additional tasks and lead additional work streams, from time to time and upon request, concerning the regulatory regime or corporate governance applicable to the Company’s business. Requires 2 years of providing regulatory guidance (analyzing and interpreting laws and regulations) or complia...
Eligibilities & qualifications....
Our client is currently seeking a Senior Manager, Regulatory Affairs. Represent regulatory affairs on project teams and support R&D and clinical research activities. Regulatory Affairs Certified is a plus. Develop and implement global regulatory strategies for investigational and marketed pharmaceut...
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...