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 global regulatory and manufacturing teams for drug product registration and commercialization

Create and manage high-quality regulatory CMC documentation and facilitate communication with stakeholders

Required Qualifications

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

5-8 years of proven 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