Sunshine Holdings
Manager – Regulatory
A short introduction
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.
Employment type (full-time/part-time) – Full Time
Requirements
- Bachelor’s degree in Marketing, Business, Statistics, Data Science, Economics, or related field
- 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