Assistant Manager Regulatory Affairs

3 weeks ago

Lahore, Punjab, Pakistan Servier Group Full time

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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 company's products comply with regulations.
  • Collect information and provide input for management to make timely decisions on regulatory compliance.
  • Prepare new product registration dossiers as per CTD format and submit to DRAP.
  • Proficiency in DRAP regulatory submission software (eAPP, etc.).
  • Timely submission of variations to registration applications and renewals.
  • Advise the company on regulatory requirements and resolve complex issues.
  • Submit license applications to authorities for approvals within timelines.
  • Expedite and obtain positive decisions on technical matters/issues with Provincial Quality Control Boards at Sindh, Punjab, Balochistan, and Khyber Pakhtunkhwa.

Network Development (Federal and Provincial Levels)

  • Develop and maintain strong relations with DRAP, Drug Control, Drug Testing Labs, Federal Inspectors, Provincial Quality Control Boards, Area Assistant Drugs Controller Offices, and the Ministry of Health.
  • Develop and maintain relations with key opinion leaders nominated by DRAP to garner positive remarks for the company's products.
  • Stay updated on new registrations, approvals, competitors' approvals, price fixation, meeting agendas, minutes, SROs, and changes in MOH.
  • Keep informed about patent developments and issues in Pakistan.
  • Maintain market intelligence on new registrations, launches, and competitors' price increases.
  • Obtain firsthand information on proceedings with the Ministry of Health, including meeting agendas, minutes, and follow-ups.
  • Coordinate with Local Finance and Head Office to submit costing data to DRAP Pricing Department.
  • Build good relations with DRAP Price Advisory Committee members to facilitate favorable price approvals.
  • Negotiate with regulatory authorities on price fixations and reviews.

At Servier, your work helps advance therapeutic progress for patients. Join teams known for scientific excellence and develop your potential in a supportive environment with onboarding, mobility, training, responsible management, and team spirit. We focus on your well-being and diversity, which enriches our mission to serve patient needs.

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