Regulatory Affairs Associate II

Hybrid working once fully trained. More on site presence whilst training.



Role Purpose:

Regulatory contractor for data management including data entry, review and labeling revisions. Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures that labeling is in compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of labeling components for regulatory dossiers. May review labeling, extract pertinent information, prepare information abstracts and ...