Manager - Regulatory Affairs

Role & Responsibilities
Lead product registrations and regulatory submissions including preparation of complex and routine filing packages
Coordinate documentation, monitor timelines, and manage regulatory project activities
Prepare responses to health authority deficiency letters
Represent Regulatory CMC in cross-functional project meetings
Monitor regulatory timelines and identify risks impacting project progression
Maintain coordination with regional and affiliate regulatory teams
Assess and approve lifecycle change requests and ensure ongoing compliance
Develop Regulatory CMC strategies for assigned products and projects
Identify and mitigate regulatory risks across product life-cycle
Attend health authority meetings and provide licensing due diligence support
Support process improvements, position papers, and regulatory work aids
Maintain technical and regulatory knowledge of global and regional CMC requirements

Qualification
Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, or related discipline

Experience
Minimum 10 years in Regulatory Affairs, R&D, Manufacturing, or related regulatory functions

Skills
Regulatory CMC strategy development
Product registrations and lifecycle management
Health authority interaction
Risk management and compliance
Cross-functional coordination
Strong project management skills
Technical regulatory documentation expertise
Leadership, mentoring, and stakeholder management

About the Company
The organization is a global life sciences company engaged in pharmaceutical development and manufacturing, supporting worldwide regulatory compliance, product registration, and lifecycle management to deliver high-quality medicines to patients globally.