Asst. Manager Regulatory Affairs

Siza Internationals Pvt. Ltd.; Lahore; On-site; PKR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Incentive Bonus

Job summary

Siza Internationals Pvt. Ltd. in Lahore, Pakistan is seeking a Regulatory Affairs professional responsible for managing DRAP regulatory activities, including new plant licensing, product registrations, and dossiers.

You will collaborate with internal teams to prepare, submit documentation and ensure compliance with regulations. You will prepare submissions, liaise with DRAP for approvals and renewals, maintain regulatory records, and support audits.

Qualifications

• 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 with DRAP and internal teams.
• Attention to detail and ability to manage regulatory timelines and follow-ups.

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.

Skills

DRAP regulations knowledge

Regulatory writing

Regulatory submissions

Documentation management

Stakeholder coordination

Job description

Company

Siza Internationals Pvt. Ltd.

Location

Lahore, Pakistan (On-site)

Employment Type

Full-Time, Morning Shift

Job 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.

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.

Qualifications

• 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.

Benefits

• Incentive Bonus