Regulatory CMC Strategist

A company is looking for a Regulatory CMC Strategist.

Key Responsibilities

Define and implement global CMC regulatory strategies for product development and lifecycle activities

Provide strategic guidance to regulatory and manufacturing teams for compliance with global regulatory requirements

Manage high-quality regulatory CMC documentation and ensure timely submissions to regulatory authorities

Required Qualifications

Bachelor's or advanced degree in a relevant scientific or regulatory discipline

5-8 years of experience in regulatory strategy within the pharmaceutical or CRO industry

In-depth knowledge of global regulatory requirements for drug development and submissions

Strong analytical and strategic thinking skills

Ability to navigate complex regulatory scenarios