
Assistant Manager Regulatory Affairs
4 weeks ago
Join to apply for the Assistant Manager Regulatory Affairs role at Servier Pakistan
Join to apply for the Assistant Manager Regulatory Affairs role at Servier Pakistan
Date posted: Jul 17, 2025
City: Lahore
Country/Region: PK
Type of Contract: Full-time Employment / Unlimited
Job Requisition ID: 8812
Assistant Manager Regulatory Affairs
Elevate Your Career with Servier Pakistan
Activities & Responsibilities:
Drug Regulatory Authority of Pakistan (DRAP)
- To develop and maintain close liaison with all offices and branches of Drug Regulatory Authority of Pakistan (DRAP) Islamabad especially with the offices/wings of Controller, Registration, QA/QC, R&D, Licensing, Pricing & Renewals, Pharmacy Services.
- Ensuring that Company's products comply with the regulations.
- Collecting information and provide input enabling the management to take timely decisions for regulatory compliance.
- Preparation of new product registration dossier as per CTD format & timely submission to DRAP.
- Proficiency in DRAP regulatory submission software (eAPP etc.).
- Timely submission of variations to registration applications and renewals of registration.
- Advising company on regulatory requirements, resolving any complex issues, if arise.
- Submitting license applications to authorities to get approvals as per timelines.
- To expedite & get positive decisions regarding technical matters/issues with Provincial Quality Control Boards at Sindh, Punjab, Balochistan and Khyber Pakhtunkhwa.
- Able to develop and maintain strong relations with DRAP, Drugs Control including Drug Testing Labs., Federal Inspectors of Drugs, Provincial Quality Control Boards, Area Assistant Drugs Controller Offices and Ministry Pharmacists.
- To develop and maintain strong relations with key opinion leaders nominated by DRAP and to be able to get positive remarks in favor of the Company's products.
- To be up to date with the information about New Registration / approval / competitors' approvals / Price fixation / Agenda of meetings / Minutes of meetings / New SROs / Changes in MOH etc.
- Keep updates and provide information regarding patent development and issues in Pakistan.
- To maintain effective market intelligence regarding new registrations, launches, and price increase endeavors by the competitors.
- To be able to get first-hand information regarding any pharmaceutical matter with Ministry of Health, i.e. inside information on different proceedings like meeting agendas, minutes of meetings and follow ups.
- Submit the Costing data after receiving from Local Finance, Head Office and coordinate with DRAP Pricing Department.
- Develop good liaison with the DRAP Price Advisory Committee members to get the price approvals in favor of the company (Hardship cases).
- Strong liaison with the officers and the related staff of Pricing Department.
- Negotiating with regulatory authorities for price fixations and reviews.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.Seniority level
- Seniority levelMid-Senior level
- Employment typeFull-time
- Job functionLegal
- IndustriesPharmaceutical Manufacturing
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