Regulatory Affairs Assistant Manager

18 hours ago


Lahore, Punjab, Pakistan beBee Careers Full time

**Regulatory Affairs Assistant Manager**

Select how often to receive an alert:

Type of Contract: Full-time Employment / Unlimited

Job Requisition ID: 8812

Regulatory Affairs Assistant Manager

Elevate Your Career

Activities & Responsibilities:

Drug Regulatory Authority of Pakistan (DRAP)

  • Develop close liaison with DRAP offices and branches, especially Controller's offices.
  • Ensure products comply with regulations.
  • Collect information for timely management decisions on regulatory compliance.
  • Prepare product registration dossiers as per CTD format and submit to DRAP.
  • Proficiency in DRAP regulatory submission software.
  • Timely submission of variations to registration applications and renewals.
  • Advise on regulatory requirements and resolve complex issues.
  • Submit license applications within timelines.
  • Expedite positive decisions from Provincial Quality Control Boards.

Network Development

  • Develop strong relations with key stakeholders at federal and provincial levels.
  • Stay updated on new registrations, approvals, competitors' approvals, price fixation, meeting agendas, minutes, SROs, and changes in MOH.
  • Maintain market intelligence on new registrations, launches, and competitors' price increases.
  • Obtain firsthand information on proceedings with the Ministry of Health.
  • Negotiate with regulatory authorities on price fixations and reviews.

We focus on advancing therapeutic progress for patients. Join teams known for scientific excellence and develop your potential in a supportive environment.



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