LifeScience Regulatory Svs Associate

Coordinate essential documentation and resources for global regulatory applications, including managing electronic submissions for CMC, amendments, annual reports, and SPL filings. Provide guidance on regulatory requirements, prepare necessary documentation, and submit reports to regulatory authorities while staying updated on regulatory changes. Conduct compliance audits to ensure the organization meets all legal and regulatory obligations efficiently. Solve routine problems largely through precedent and referral to general guidelines within a team with a predetermined, focused scope of work. This role may require working in rotational shifts.