Global Regulatory Affairs Specialist — Dossier Expert

Pintern; Karachi Division; Vor Ort; PKR 700.000 - 1.100.000; Vollzeit

Zusammenfassung

Winthrox Laboratories Pvt. Ltd. in Karachi is seeking an Officer Regulatory Affairs to manage regulatory activities for domestic and export markets. You will prepare and submit dossiers, monitor approvals, and ensure compliance with international standards.

The role requires Pharm-D with at least 1 year of regulatory experience, strong communication skills, and proficiency in MS Office. You will work closely with cross-functional teams to meet timelines and regulatory commitments.

Qualifikationen

• Pharm-D with 1 year minimum experience in regulatory affairs.
• Experience in preparing, reviewing and submitting regulatory dossiers to international authorities.
• Knowledge of USFDA, EMA, EU, WHO and global regulatory requirements.
• Experience with product registrations, renewals and variations for export markets.
• Strong written and verbal communication skills.
• Advanced in Microsoft Office: Word, Excel, PowerPoint, Project, Outlook, Access.
• Target-oriented with strong time management.

Kenntnisse

Regulatory affairs

Dossier preparation

Regulatory submissions

Communication skills

Time management

Team collaboration

Ausbildung

Pharm-D

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Microsoft Outlook

Microsoft Access

Jobbeschreibung

Winthrox Laboratories Pvt. Ltd. in Karachi is seeking an Officer Regulatory Affairs to manage regulatory activities for domestic and export markets. You will prepare and submit dossiers, monitor approvals, and ensure compliance with international standards.

The role requires Pharm-D with at least 1 year of regulatory experience, strong communication skills, and proficiency in MS Office. You will work closely with cross-functional teams to meet timelines and regulatory commitments.