Job Description
TAKING SRI LANKA TO THE WORLD
MANAGER – REGULATORY
This role is responsible for leading and managing Regulatory Affairs activities to ensure full compliance with pharmaceutical regulatory requirements and support business growth through timely product registrations and approvals. The position involves preparing and coordinating regulatory submissions, maintaining regulatory documentation, liaising with regulatory authorities, monitoring regulatory changes, and ensuring compliance with NMRA, GMP, and other applicable standards. The role also supports audits and inspections, provides regulatory guidance on product-related documentation, manages regulatory risks, and drives continuous improvement of regulatory processes while leading and developing the Regulatory team.
PERSONAL PROFILE
- Bachelor’s Degree in Science, Pharmacy, or a related discipline (Master’s Degree in Science, Pharmacy, Business Management, or a related field will be an added advantage)
- Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical industry
- Strong knowledge of NMRA, GMP, and other applicable pharmaceutical regulatory requirements
- Proven experience in regulatory submissions, product registrations, renewals, variations, and compliance management
- Experience in liaising with regulatory authorities and managing regulatory documentation
- Strong analytical, problem solving, and decision making skills
- Excellent communication, stakeholder management, and organizational abilities
- Ability to manage multiple priorities and work effectively in a highly regulated environment
- Proficiency in Microsoft Office and regulatory management systems/software
Lina Manufacturing, acquired by Sunshine in 2021, serves as the manufacturing arm of Sunshine Healthcare, specializing in respiratory products. It is the only local manufacturer of metered dose inhalers (MDIs) and a key manufacturer of dry powder inhalers (DPIs) in Sri Lanka. The company supplies a range of therapeutic products including dry powder capsules, tablets, nasal sprays, devices, and creams, to both government and private sectors, with a strong focus on treatment of asthma & COPD. With ongoing investments in research and development, Lina aims to expand its portfolio with more advanced products, strengthening local pharmaceutical manufacturing.
