Regulatory Operations – Level 2 - Publisher (Contractor)

Job description

Overview This role will support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission Gateways (ESG), as well as, prepare and file non-eCTD submissions to ensure compliance with applicable laws and regulations. This includes publishing regulatory documents, managing document tracking and version control, maintaining a thorough understanding of regulatory requirements, collaborating with cross-functional teams, and identifying opportunities for process improvement. Responsibilities: - Support in the preparation and submittal of regulatory applications and on‐going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, NDA/BLA, MAA, CTA, DMF). - Ensure consistency across regulatory submission documents following the regulatory style guide (i.e. formatting, reviewing, and submissions). - Provide technical expertise to cross-functional teams on structure of compliant documents for electronic submissions. - Coordinate with cross-functional teams, including Regulatory Affairs, Clinic...