Parexel is seeking a Senior Regulatory Associate to author general CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs. You will prepare CMC packages, support GMP submissions, manage change control assessments, and ensure regulatory compliance across regions.
Ideal candidates have at least 5 years in biotech/pharma regulatory affairs, strong M3 authoring experience, and solid cross-regional regulatory knowledge. Remote work options are available.