Regulatory Affairs Executive

We're Hiring: Regulatory Affairs Executive

Amros Pharmaceuticals is looking for a highly skilled and detail-oriented RA Executive to manage the preparation, review, and submission of regulatory dossiers for both local and international markets while ensuring full compliance with regulatory guidelines.

Qualification:

• Pharm-D from a recognized institution.
• 2 to 3.5 years of experience in Regulatory Affairs.
• Proficiency in MS Office, DRAP Portal, and PSW.

Key Responsibilities:

• Prepare and review CTD and ACTD dossiers for local and international submissions.
• Prepare CPI applications and quota applications as per regulatory requirements.
• Submit documents and ensure timely query compliance for export-related submissions.
• Handle hardship cases by preparing and reviewing necessary documentation.
• Maintain, review, and ensure the accuracy of all regulatory records and data.
• Correspond with internal and external stakeholders regarding dossier requirements, updates, and submissions.
• Ensure compliance with regulatory frameworks and support continuous improvement in dossier quality.

Location: Ahsanabad, SITE Area II, Karachi.

Timings: 8:30 AM – 5:30 PM

Apply Now:

Send your updated profile to hr.recruitment@amrospharma.com

Job Type: Full-time

Work Location: In person