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Regulatory Consultant (CMC Module 3) at Syneos Health - ApplyBlast

Regulatory Consultant (CMC Module 3)

Syneos Health

5 months ago

Remote

Full Time

Senior

0 applicants

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About this role

A Regulatory Affairs Consultant at Syneos Health specializes in Module 3 (CMC) documentation for post-approval submissions and lifecycle management activities, supporting regulatory variations and site transfers.

Responsibilities

Author and review Module 3 documentation for post-approval submissions
Prepare and support CMC variation applications
Manage site transfer submissions and regulatory strategy
Collaborate with cross-functional teams for data collection
Track and manage regulatory activities for timely submission

Skills

Qualifications

M.PharmM.Sc.Life Sciences Degree

About Syneos Health

syneoshealth.com

Headquarters

Morrisville, North Carolina, United States

Company Size

10001+ employees

Founded

2017

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Syneos Health is a biopharma solutions organization and full‑service contract research organization (CRO) that integrates clinical development, regulatory and commercialization services to help life‑science companies bring therapies to market faster. It provides end‑to‑end capabilities — clinical trials across phases and therapeutic areas, real‑world evidence and data analytics, medical affairs, market access, patient engagement and commercial launch services. With a global network of scientific, clinical and commercial experts, Syneos partners with biopharma, biotech and medtech clients to de‑risk development programs and accelerate product adoption.