Regulatory Affairs Manager (5–10 Years)

Job Description

The Regulatory Affairs Manager oversees regulatory strategies for product approvals, manages RA teams, and ensures compliance with global and local regulations.

Key Responsibilities

• Lead regulatory submissions and approvals for new and existing products

• Develop regulatory strategies and timelines for product registration

• Review labeling, advertising, and promotional materials for compliance

• Liaise with global and local regulatory authorities

• Lead and mentor RA staff

• Support audits, inspections, and risk management activities

• Maintain up-to-date knowledge of regulatory changes and implement SOP updates

Skills & Requirements

• 5–10 years of regulatory affairs experience

• Strong leadership and team management skills

• In-depth knowledge of local and global regulatory frameworks

• Proven experience in dossier preparation, submissions, and regulatory strategy