Description

Job Description

Job Purpose:

• To prepare, compile, and submit high-quality regulatory documentation to health authorities to gain and maintain marketing authorizations for the company’s products. This role ensures that all activities are performed in strict compliance with the applicable regulations for the assigned domain.

Key Accountabilities and Decision Ownership:

• Compile, format, and review scientific and technical data to prepare regulatory dossiers (e.g., CTD modules) for new products, variations, and renewals.
• Prepare and manage documentation for international product registrations, including legal documents and responses to queries from foreign agents/authorities.
• Maintain detailed and organized records of all regulatory submissions, correspondence, and approvals.
• Review product labeling, leaflets, and promotional materials for regulatory compliance.
• Stay updated with current regulations and guidance documents relevant to the assigned area.
• (For Senior Specialist) Mentor junior specialists, handle more complex submissions, and contribute to regulatory strategy discussions.

Technical & professional qualifications:

• Bachelor’s degree in Pharmacy or a related Life Science is required.
• 1-3 years of experience in regulatory affairs or a related field (e.g., QA, R&D).

Skills:

• Technical Writing
• Organizational Skills
• Microsoft Office (Word, Excel)
• Problem-Solving
• Communication