Regulatory Affairs Manager

5 days ago

Lahore, Punjab, Pakistan beBeeRegulatory Full time 800,000 - 1,200,000

We are seeking a talented Regulatory Affairs professional to join our team.

This role will be responsible for ensuring the company's products comply with regulatory requirements and managing relationships with government agencies.

Key Responsibilities:
  • 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 regulations.
  • Collecting information and providing input enabling the management to take timely decisions for regulatory compliance.
  • Preparing new product registration dossiers 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 on regulatory requirements, resolving any complex issues, if arise.
  • Submitting license applications to authorities to get approvals as per timelines.
Network Development (Federal as well as Provincial Levels):
  • 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.
Regulatory Intelligence/Updates:
  • To be up to date with 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.
Pricing Issues:
  • Submit 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.
About Us:

We are a forward-thinking organization dedicated to advancing therapeutic progress for the benefit of patients. We foster an environment that encourages growth and recognizes individual contributions.

Seniority level:
  • Mid-Senior level
Employment type:
  • Full-time
Job function:
  • Legal
  • Industries: Pharmaceutical Manufacturing

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