Experience7 Years
Salary range100,000–150,000PKR
Career levelNon-Managerial
What you’ll be doing
Siza Internationals Pvt. Ltd., a pharmaceutical company based in Lahore, is seeking an experienced Regulatory Affairs Professional to manage regulatory compliance and product lifecycle activities.
Key responsibilities include:
Key responsibilities include:
- Prepare and manage submissions for new plant licensing and new product registrations.
- Compile, review, and maintain regulatory documentation for new molecule registrations, renewals, and variations.
- Draft clear regulatory correspondence and responses for DRAP queries and inspections.
- Monitor and interpret DRAP regulations and pharmaceutical legislation to ensure company compliance.
- Coordinate with cross-functional teams (QA, Production, R&D) to gather required dossiers and technical information.
- Track submission timelines, follow up on approvals, and maintain accurate records of regulatory activities.
What we’re looking for
- Must-have: Practical knowledge of DRAP regulations, guidelines, and pharmaceutical legislation in Pakistan.
- Must-have: Proven experience preparing regulatory dossiers for new plant licensing and product registration.
- Must-have: Strong regulatory writing, documentation, and submission skills.
- Must-have: Experience liaising with regulatory authorities and managing queries, approvals, and renewals.
- Must-have: Ability to coordinate with internal teams (QA, Production, R&D) to collect technical and quality documentation.
- Must-have: Attention to detail, organization, and ability to manage multiple regulatory submissions and timelines.
Perks & benefits
- check_circleIncentive Bonus
Siza Internationals Pvt. Ltd. arrow_forward
Pharmaceuticals · Lahore, Pakistan
About Us
Siza International (Pvt.) Ltd. is one of Pakistan's leading pharmaceutical manufacturers, established in 1985. The company is committed to delivering high-quality, affordable healthcare solutions through continuous innovation, advanced manufac
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