Assistant Manager Regulatory Affairs

2 weeks ago

Lahore, Punjab, Pakistan Servier Pakistan Full time

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)
  • Develop and maintain close liaison with all offices and branches of DRAP Islamabad, especially with the offices/wings of Controller, Registration, QA/QC, R&D, Licensing, Pricing & Renewals, Pharmacy Services.
  • Ensure that company's products comply with regulations.
  • Collect information and provide input to enable management to make timely decisions for regulatory compliance.
  • Prepare new product registration dossiers as per CTD format and submit them to DRAP.
  • Proficiency in DRAP regulatory submission software (eAPP, etc.).
  • Submit variations to registration applications and renewals of registration in a timely manner.
  • Advise the company on regulatory requirements and resolve complex issues as they arise.
  • Submit license applications to authorities to obtain approvals within specified timelines.
  • Expedite and secure positive decisions regarding technical matters/issues with Provincial Quality Control Boards in Sindh, Punjab, Balochistan, and Khyber Pakhtunkhwa.
Network Development (Federal and Provincial Levels)
  • Develop and maintain strong relations with DRAP, Drugs Control, Drug Testing Labs, Federal Inspectors of Drugs, Provincial Quality Control Boards, Area Assistant Drugs Controller Offices, and the Ministry of Pharmacists.
  • Build and sustain strong relations with key opinion leaders nominated by DRAP to garner positive remarks for the company's products.
Regulatory Intelligence/Updates
  • Stay updated on new registration approvals, competitors' approvals, price fixation, meeting agendas, minutes, SROs, and changes in MOH regulations.
  • Provide updates and information on patent developments and issues in Pakistan.
  • Maintain effective market intelligence on new registrations, product launches, and competitor price increases.
  • Gather first-hand information on pharmaceutical proceedings with the Ministry of Health, including meeting agendas and follow-ups.
Pricing Issues
  • Submit costing data received from local finance and head office, coordinating with DRAP Pricing Department.
  • Develop good relations with DRAP Price Advisory Committee members to secure favorable price approvals, including for hardship cases.
  • Liaise with officers and staff of the Pricing Department.
  • Negotiate with regulatory authorities on price fixations and reviews.

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages development. We offer tailored onboarding, mobility opportunities, quality training, responsible management, and a team-oriented workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We value diversity among our employees as a vital resource for fulfilling this mission.

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