Remote CMC Regulatory Affairs Associate — Submissions
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Parexel is seeking a Senior Regulatory Associate to author global 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.
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CMC Regulatory Affairs Associate
Hace 1 semana
Mexico, chihuahua Parexel Jornada completaJoin Our Growing Team of CMC Regulatory Professionals!The Senior Regulatory Associate will author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests. Responsibilities include preparing and reviewing CMC packages, supporting GMP submissions, managing change control...
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mexico Parexel Jornada completaParexel is seeking a Senior Regulatory Associate to author global 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...
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CMC Regulatory Affairs Associate
Hace 2 días
mexico Parexel Jornada completaJoin Our Growing Team of CMC Regulatory Professionals!The Senior Regulatory Associate will author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests. Responsibilities include preparing and reviewing CMC packages, supporting GMP submissions, managing change control...
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Sr. Associate, Regulatory Strategy
Hace 1 día
Mexico City, Mexico City Parexel Jornada completaWhen our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at...