We're a leading recruitment company in Sri Lanka looking for a Senior Manager - Regulatory Affairs for a leading Pharmaceutical company based in Colombo. This role is critical in ensuring timely product registrations, ongoing compliance, and effective coordination with regulatory authorities and international partners.

Key Responsibilities:

Regulatory Leadership: Lead and manage all regulatory affairs related to product registration, licensing, and regulatory compliance.
Product Registration Oversight: Oversee and ensure the timely registration of pharmaceutical products with the National Medicines Regulatory Authority (NMRA) and other relevant regulatory bodies.
Licensing & Compliance: Ensure all required licenses, renewals, and approvals are obtained and maintained in line with local and international regulatory requirements.
Stakeholder Coordination: Act as the primary liaison with regulatory authorities and collaborate closely with foreign suppliers and partners on regulatory matters.
Team Management: Guide, mentor, and support the regulatory affairs team to ensure accuracy, efficiency, and compliance in all submissions and activities.
Sample & Documentation Management: Oversee the preparation, review, and submission of regulatory documentation and product samples.
Customs & Import Support: Ensure regulatory documentation is in place to facilitate smooth customs clearance and importation of pharmaceutical products.
Regulatory Updates: Monitor changes in regulatory guidelines and legislation, advising management on compliance risks, requirements, and continuous improvement opportunities.

Key Requirements:

Education:
- Degree in Pharmacy, Life Sciences, or a related discipline.
- Postgraduate qualifications in regulatory affairs or a related field will be an advantage.
Experience:
- Minimum 5 years of experience in pharmaceutical regulatory affairs.
- Prior managerial or supervisory experience is preferred.
Skills & Competencies:
- Strong knowledge of NMRA regulations and pharmaceutical registration processes.
- Excellent organizational, communication, and stakeholder management skills.
- Proven ability to lead teams and manage multiple regulatory projects simultaneously.