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Regulatory Labeling Manager at Syneos Health - ApplyBlast

Regulatory Labeling Manager

Syneos Health

1 month ago

Remote

Full Time

Manager

0 applicants

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About this role

The Regulatory Labeling Manager is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products. This role involves authoring and updating labeling documents in response to safety updates, regulatory requirements, and internal assessments. The manager collaborates with internal stakeholders to ensure governance processes are followed and labeling decisions are well-documented.

Responsibilities

Plan and lead labeling updates driven by safety changes and regulatory commitments
Author and revise labeling documents including CCDSs, USPI, and SmPC
Support labeling governance activities and ensure compliance with regulatory requirements

Skills

About Syneos Health

syneoshealth.com

Headquarters

Morrisville, North Carolina, United States

Company Size

10001+ employees

Founded

2017

View Profile

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.