Industry:Pharmaceuticals
Sector:Administration
Location: Karachi, Pakistan
Qualification:MSc. Biology or Equivalent
Experience:3 - 5 Years
One of Pakistan’s leading pharmaceutical companies is looking to hire an Assistant Manager – Regulatory Affairs for its Diagnostics Division in Karachi. The ideal candidate should have a Master’s Degree in Biological Sciences or in a relevant field along with 3 to 5 years of experience in regulatory affairs. Experience pertaining to managing and handling medical devices will be preferred. Travelling will be required of the individual, as and when needed.
Assistant Manager Regulatory Affairs will be responsible for handling all affairs related to Drug Approval Authority of Pakistan regarding registration, approval and maintaining listings of drugs.
Job Responsibilities:
- Prepare, and submit registration dossiers for medical devices registration in the required format.
- Follow-up input request from Drug Regulatory Authority of Pakistan to ensure successful product registration.
- Submit supplementary for approved products when there is an update of the dossier.
- Ensure local regulations are observed and implemented within the company.
- Coordinate with global regulatory and DRAP for all regulatory related issues.
- Assist in the preparation of the GDPMDS (Good Distribution Practice for Medical Devices) audit.
- Maintain the PMDR (Pakistan Medical Device Register) Listing for approved products.
- Maintain the registration status in SAP.
Skills:
- Understanding of pharmaceutical regulatory affairs.
- Time Management.
- Detail oriented.
- Excellent communication skills – verbal and written.
Apply by sending your updated CV to: fahad@hasnain.biz
Kindly mention Assistant Manager – Regulatory Affairs in the subject.
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