Regulatory Affairs Officer

Description:

Responsibilities

• Prepare and submit CTD / ACTD dossiers for international markets, handle queries and follow up till registration.

• Ensure that all product registrations and submissions comply with applicable laws, guidelines, and industry standards.

• Prepare other supporting regulatory documents as required by foreign regulatory agencies.

•Collaborate with QA, QC, Production, and Export departments to gather accurate and up-to-date technical and manufacturing data for dossier completion.

• Maintain clear and continuous communication with international stakeholders regarding dossier status and updates.

• Maintain accurate and updated records of all submitted dossiers, correspondence, and regulatory approvals.

Qualifications

• Education: Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences.

• 6 months to 1 year in regulatory affairs for the pharmaceutical industry.

• Proficiency in CTD format preparation and dossier compilation.

• Excellent written and verbal communication skills.

• Ability to work effectively under tight deadlines