Manager Regulatory Affairs
Siza Internationals Pvt. Ltd.Required skills
Seeking a Manager Regulatory Affairs to lead licensing and product registration activities for pharmaceutical products in Lahore, Pakistan. Join Siza Internationals Pvt. Ltd. and utilize your regulatory expertise to ensure compliance with DRAP regulations and pharmaceutical legislation.
Original job description
Source: mustakbil.comLocation: Lahore, Pakistan (On-site)
Employment Type: Full-Time
Shift: Morning Shift
Role Summary:
- Manage licensing and product registration activities for pharmaceutical products.
- Prepare and maintain regulatory documentation for registrations, renewals, and regulatory filings.
- Prepare and submit registrations for new products and new molecular entities.
- Manage new plant licensing processes and prepare required submissions.
- Correspond with DRAP for submissions, approvals, renewals, queries, and other regulatory matters.
- Ensure compliance with DRAP regulations and applicable pharmaceutical legislation.
- Produce regulatory writing and technical documents with accuracy and clarity.
- 5 to 7 years of regulatory affairs experience in the pharmaceutical industry.
- Strong knowledge of DRAP regulations and pharmaceutical legislation in Pakistan.
- Experience in new plant licensing and product registration processes.
- Regulatory writing, documentation, and submission preparation skills.
- Ability to manage correspondence and interactions with regulatory authorities (DRAP).
- Attention to detail and ability to maintain regulatory records and timelines.
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