Asst. Manager Regulatory Affairs
Siza Internationals Pvt. Ltd.Required skills
Asst. Manager Regulatory Affairs at Siza Internationals Pvt. Ltd. in Lahore, PK. Manage regulatory activities and ensure compliance with DRAP regulations. Full-time, morning shift. Strong knowledge of pharmaceutical legislation and excellent regulatory writing skills required.
Original job description
Source: mustakbil.comLocation: Lahore, Pakistan (On-site)
Employment Type: Full-Time, Morning Shift
Role Summary:
Responsible for managing regulatory activities including new plant licensing, product registrations, regulatory submissions, correspondence with DRAP, approvals, and renewals. Work closely with internal teams to prepare and submit documentation and ensure compliance with DRAP regulations and pharmaceutical legislation.
Key Responsibilities:
- Prepare and submit applications for new plant licensing.
- Compile and manage documentation for new product and new molecule registrations.
- Prepare regulatory submissions, dossiers, and licensing documents.
- Correspond and follow up with DRAP for submissions, approvals, renewals, and regulatory queries.
- Ensure compliance with DRAP regulations and pharmaceutical legislation.
- Maintain accurate regulatory records and support audits or inspections as needed.
- Must-have: Strong knowledge of DRAP regulations and pharmaceutical legislation.
- Excellent regulatory writing and documentation skills.
- Experience preparing regulatory submissions, dossiers, and licensing documents.
- Good communication and stakeholder coordination skills for interacting with DRAP and internal teams.
- Attention to detail and ability to manage regulatory timelines and follow-ups.
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