Hasnain Tanweer Associates Logo

Senior Officer Regulatory Affairs

Senior Officer Regulatory Affairs job in Karachi

Industry: Pharmaceuticals

Sector: Others

Location: ,

Qualification: Bachelors

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.

 

Responsibilities: 

  • 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.

 

Skills:

  • Communications skills
  • Analytical skills

 

 

Apply now at fahad@hasnain.biz

Kindly mention the job title Senior Officer Regulatory Affairs in the email.

Last date to apply for the job is 24th February, 2018

To apply Online Fill-in the form below and submit Fields marked with asterisk(*) are mandatory.