Job Summary
The Regulatory Affairs Specialist ensures that pharmaceutical products comply with all applicable regulatory requirements throughout their lifecycle. This role supports product registration, maintenance, and compliance activities while coordinating with internal teams and regulatory authorities to enable timely market access.
Key Responsibilities
- Prepare, compile, and submit regulatory dossiers for product registration, renewal, variation, and amendment in accordance with local regulatory requirements
- Maintain product licenses and ensure timely submission of post-approval commitments and regulatory updates
- Liaise with regulatory authorities to address queries, deficiencies, and clarifications
- Monitor changes in regulatory guidelines and assess impact on existing and pipeline products
- Ensure compliance of product labeling, packaging materials, and promotional claims with approved registrations
- Support regulatory strategy execution for new product launches and line extensions
- Coordinate with cross-functional teams (Quality, Medical, Supply Chain, Marketing) on regulatory matters
- Maintain accurate regulatory documentation and databases
- Assist in audits, inspections, and internal compliance reviews as required
Qualifications & Requirements
- Bachelor's degree in Pharmacy
- Licensed Pharmacist
- At least 3 years of experience in Regulatory Affairs within the pharmaceutical or healthcare industry
- Working knowledge of local regulatory requirements and submission processes
- Strong attention to detail and document management skills
- Good written and verbal communication skills
- Ability to manage multiple submissions and meet regulatory timelines
