Senior Regulatory Affairs Manager

A company is looking for a Sr Manager, Regulatory Affairs.

Key Responsibilities

Prepare and submit moderately complex regulatory submissions and documents for investigational and commercial products

Ensure product packaging and associated information are updated in accordance with product licenses

Maintain up-to-date knowledge of regulatory requirements and communicate changes to project teams and senior management

Required Qualifications

Bachelor's Degree with 8 years of experience, Master's Degree with 6 years of experience, or a PhD

Knowledge of regulatory requirements, including ICH and regional requirements

Capability to develop and implement regulatory strategy

Experience in leading a small team in preparation of submissions

Ability to provide strategic regulatory advice as appropriate