Katalyst Healthcares and Life Sciences
Regulatory Affairs Specialist
Katalyst Healthcares and Life Sciences, Hoboken, New Jersey, us, 07030
Responsibilities
Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company.Keeps abreast of regulatory procedures and changes.Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents.ssists in the preparation of international registration dossiers for use in international registration by affiliates.Participates with internal/external teams and builds professional relationships.Identifies and suggests solutions to Regulatory tasks.Requirements
Bachelor's Degree or equivalent5 years of related Regulatory Affairs experience.bility to travel based on business needs.
Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company.Keeps abreast of regulatory procedures and changes.Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents.ssists in the preparation of international registration dossiers for use in international registration by affiliates.Participates with internal/external teams and builds professional relationships.Identifies and suggests solutions to Regulatory tasks.Requirements
Bachelor's Degree or equivalent5 years of related Regulatory Affairs experience.bility to travel based on business needs.