Regulatory Associate (eu Mkt, Cmc Module 3)

Syneos Health

Multiple Locations
On-site
Cmc experience in small molecule
Eu market experience
Regulatory submission documents preparation
Assists with preparation of product development documents including gap analyses and clinical development plans

Job Summary

  • Assists with preparation of product development documents including gap analyses and clinical development plans.
  • Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.
  • We are continuously building the company we all want to work for and our customers want to work with.

Matching Summary

Assists with preparation of product development documents including gap analyses and clinical development plans.

Skills & Requirements

Must-have

  • CMC experience in small molecule
  • EU market experience
  • Regulatory submission documents preparation
  • Regulatory research

Nice-to-have

  • Develops people through career progression
  • Inclusive and authentic culture
  • Agile and driven to deliver

Key Requirements

  • Minimum 6 months to 2 years of experience
  • Internship preferred
  • Fluent in speaking, writing, and reading English

Work Rights

Not specified

Tailored Resume

Cover Letter