PHI Access - KAM

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.
• (For Local) Prepare and submit registration files to the EDA and handle responses to agency deficiencies.
• 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.
• Cross functional collaboration with different departments like R&D , QC, QA And supply chain involved in all regulatory and technical submissions

Qualifications and Education:

• Bachelor’s degree in Pharmacy or a related Life Science is required.
• Specialist: 1-3 years of experience in regulatory affairs or a related field (e.g., QA, R&D).
• Experience with CTD format and electronic submission platforms is a strong advantage.