Manager Regulatory Affairs

Siza Internationals Pvt. Ltd.; Lahore; On-site; PKR 1,800,000 - 3,000,000; Full time

Benefits offered by this job

Incentive Bonus

Job summary

Siza Internationals Pvt. Ltd. in Lahore, Pakistan, is seeking an experienced Regulatory Affairs professional to manage licensing and product registration activities for pharmaceutical products.

You will prepare regulatory documentation for registrations, renewals, and filings, submit for new products and new molecular entities, coordinate with DRAP, and ensure compliance with local legislation. The role requires meticulous regulatory writing, documentation, and timely submissions.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory affairs

Regulatory writing

Documentation & submissions

Regulatory correspondence with DRAP

Attention to detail

Job description

Job Description

Company: Siza Internationals Pvt. Ltd.

Location: 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.

Job Specification

• 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.

Job Rewards and Benefits

Incentive Bonus