Assistant Manager - Regulatory and Legal Affairs
About the Employer
Job Description
CHALLENGING CAREER IN A SRI LANKAN MANUFACTURING COMPANY
We are seeking a highly motivated and detail-oriented Assistant Manager – Regulatory Affairs to join our team. The ideal candidate will be responsible for managing regulatory submissions, ensuring compliance with the National Medicines Regulatory Authority (NMRA) of Sri Lanka, and supporting product registrations, renewals, and compliance activities. Experience in handling local manufacturing dossiers will be an added advantage.
ASSISTANT MANAGER - REGULATORY AND LEGAL AFFAIRS
Key Responsibilities
- Prepare, review, and submit regulatory dossiers for product registrations, variations, and renewals to NMRA.
- Ensure all products comply with NMRA regulations and other relevant guidelines.
- Maintain up-to-date knowledge of local and international regulatory requirements.
- Liaise with NMRA officials and coordinate regulatory inspections, audits, and approvals.
- Monitor changes in regulatory policies and advise the company on compliance strategies.
- Work closely with R&D, Quality Assurance, and Manufacturing teams to ensure regulatory compliance in all aspects of product development.
- Handle regulatory documentation, including the preparation of DDT (Common Technical Document) formats and labeling approvals.
- Manage regulatory submissions for locally manufactured pharmaceutical products and ensure compliance with GMP requirements.
- Respond to regulatory queries and provide technical justifications as needed.
- Assist in pharmacovigilance activities and regulatory reporting obligations.
- Conduct internal training sessions on regulatory compliance and updates.
Qualifications & Experience
- Bachelor’s degree in Pharmacy, Biotechnology, Life Sciences, Chemistry, or a related field.
- 2+ years of experience in Regulatory Affairs within the pharmaceutical, medical device, or healthcare industry in Sri Lanka.
- Experience in understanding NMRA regulations, WHO GMP guidelines, and other local regulatory requirements.
- Experience in dossier preparation for locally manufactured pharmaceutical products is a strong advantage.
- Familiarity with pharmacovigilance requirements and post-marketing surveillance regulations.
- Excellent communication skills for liaising with regulatory authorities and internal teams.
- Strong analytical skills and attention to detail.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and regulatory submission software/tools.
Preferred Skills
- Experience in handling biologics, medical devices, or cosmetics regulatory approvals.
- Knowledge of international regulatory guidelines (ICH, US FDA, EMA) is an advantage.
- Ability to manage multiple projects and work under deadlines.
Benefits
- Competitive salary and performance-based incentives.
- Career growth opportunities in a leading pharmaceutical/healthcare organization.
- Exposure to international regulatory frameworks and professional development programs.
Interested candidates are encouraged to submit their resume and cover letter detailing relevant experience and qualifications.
Email: [email protected]
Universal Lifeline Ceylon (Pvt) LTD
No. 109/3, Industrial Area,
Purana Mirigama, Mirigama, Sri Lanka
Tel: 0332 210 222
www.universal-lifeline.com
