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Regulatory Device CMC Manager at Syneos Health - ApplyBlast

Regulatory Device CMC Manager

Syneos Health

3 months ago

Onsite

Full Time

Senior

0 applicants

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About this role

A Regulatory Device CMC Manager at Syneos Health supports strategies for marketed and development products within the life sciences sector. The role involves preparing and submitting regulatory CMC documentation for combination devices and providing guidance to cross-functional teams on global regulatory requirements. Key duties include reviewing regulatory submissions, developing global strategies, and ensuring compliance with FDA, EMA, and ICH guidelines.

Responsibilities

Prepare and submit regulatory CMC documentation for combination devices
Review device sections of regulatory submissions and agency interactions
Develop global regulatory device strategies for commercial products
Provide regulatory guidance on product compliance and change controls
Collaborate with cross-functional teams on global drug device CMC strategies

Skills

Qualifications

Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life-science field

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.