Senior Regulatory Affairs Executive – Pharmaceuticals & Medical Devices
- Sri Lanka
Job Duties
• Prepare, compile and submit high-quality regulatory dossiers and supporting documents to local and international authorities for product registrations and certifications.
• Liaise with regulatory bodies to monitor application status and ensure timely responses to queries or deficiencies.
• Maintain a comprehensive tracking system for submissions, renewals and expiries.
• Coordinate internal and external audits to obtain and maintain GMP certifications for manufacturing sites.
• Support validation and qualification activities related to product and process approvals.
• Support documentation control, including version management, revision tracking and process validation.
• Develop and maintain professional relationships with regulatory bodies, certification agencies, trade associations and healthcare institutions.
• Represent the organization at industry forums, regulatory meetings and inspections.
• Gather regulatory intelligence to foresee industry trends and prepare proactive responses.
• Support Sisili's five-year strategic plan by facilitating required registrations in line with planned timelines.
Requirements
• SLMC-registered pharmacist; a professional certification, diploma or degree in Pharmacy is an advantage.
• Minimum 3-4 years of hands-on experience in regulatory roles, preferably in a healthcare or pharmaceutical manufacturing environment.
• Understanding of regulatory requirements across surgical, pharma and wellness product categories (especially Medical Devices).
• Exceptional attention to detail, particularly in documentation and legal submissions.
• Effective communication and negotiation skills with internal and external stakeholders.
• Ability to work independently and collaboratively in cross-functional teams.
• Proficiency in document control systems, regulatory databases and MS Office.