
Regulatory Affairs Assistant Manager
18 hours ago
**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 ManagerElevate 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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