Job Description
Be Part of the People Who Make Delmege Great
Assistant Manager-Regulatory Affairs
Established as one of Sri Lanka's most respected and diversified conglomerates, Delmege has built a trusted reputation for delivering excellence across diverse sectors. With a footprint in Interior Decor & Lifestyle Solutions, Healthcare, FMCG, Energy Solutions, Insurance Brokering, Shipping and Logistics, Travel and Aviation, we empower our people to innovate, grow, and lead. We invite passionate professionals to be a part of our historic journey and shape the Delmege Group's future with us.
Key Responsibilities
- Ensure compliance with all applicable regulatory requirements, standards, and guidelines related to medical equipment and healthcare products.
- Prepare, submit, and manage regulatory documentation including product registrations, renewals, variations, and import license applications.
- Develop and implement regulatory strategies to support product registration, market access, and commercialization objectives.
- Monitor regulatory updates, industry developments, and legislative changes, assessing their impact on business operations and products.
- Liaise with regulatory authorities and other external stakeholders to facilitate approvals and maintain regulatory compliance.
- Ensure compliance with quality management system requirements through documentation management, audits, and corrective actions.
- Identify regulatory risks and implement effective mitigation plans to ensure uninterrupted business operations.
- Conduct warehouse inspections and maintain regulatory standards for storage and distribution activities.
- Collaborate with cross-functional teams including Operations, Finance, HR, and Legal to support compliance initiatives and business objectives.
Qualifications & Experiences
- Bachelor's Degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related field.
- 10-12 years of experience in Regulatory Affairs or a similar role within the pharmaceutical, medical device, or healthcare industry.
- Strong knowledge of regulatory requirements, product registration processes, and healthcare industry compliance standards.
- Proven experience in managing regulatory submissions and maintaining relationships with regulatory authorities.
- Excellent analytical, problem-solving, and risk assessment skills.
- Strong communication, negotiation, and stakeholder management abilities.
- High attention to detail with strong organizational and time management skills.
- Demonstrated leadership capabilities and ability to work effectively across cross-functional teams.
Delmege Forsyth & Co. Ltd. 101, Vinayalankara Mawatha, Colombo 10.
