Experience: 2 to 5 years
Senior Officer Regulatory Affairs job in Karachi with a Pharmaceutical company. Resource required having Bachelors degree or Pharm D with 2 to 5 years experience. Interested candidates apply now for the job.
Senior Officer Regulatory Affairs job role is to keep updated & continuously review changes in product medical guidelines.
- Develop registration dossiers for local registration incorporating all the aspects of dossiers development including compilation & submission as per the prescribed format of DRAP. Timelines / Deadlines to be developed & followed on dossier development & submission
- Developing, compiling, reviewing & dispatching product registration dossiers on ACTD & CTD format for both, existing drug molecules as well as of new chemical entities.
Keep updated on international legislation & medical guidelines for registration of existing DRAP molecules & new chemical entities for export.
- Keep updated & continuously review changes in product medical guidelines (Prescription lnformation) & incorporate the same in the existing approved guidelines
- Collect & evaluate prescription, scientific & marketing data from IMS & suggest potential products for registration.
- Develop cross-check & verify product artworks as per DRAP guidelines for products to be registered for local manufacturing as well as for exports.
- Correspond with DRAP on all products registration issues, pricing, renewal of manufacturing / license & maintain a log sheet on these correspondences.
- Keep record of all the registration files (Local & Export), Drug Manufacturing License, its Renewal Data etc
- Attain COPP & FSC required for export or otherwise, by coordinating with DRAP, KCCI / MOFA & Embassies of Relevant countries.
- Communications skills
- Analytical skills
Apply now at email@example.com
Kindly mention the job title Senior Officer Regulatory Affairs in the email.
Last date to apply for the job is 24th February, 2018
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