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ATCO Laboratories Ltd Jobs Manager Regulatory Affairs



ATCO Laboratories Ltd Jobs Manager Regulatory Affairs:

Organization: ATCO Laboratories Ltd

Position: Manager Regulatory Affairs
Qualification: B. P.h.a.r.m / P.h.a.r.m D
Experience: 8-10 Yearsโ€™ of extensive experience looking after the International / Domestic Regulatory Affairs in a Reputable P.h.a.r.m.a.c.e.u.t.i.c.a.l Company. Preference will be given to those candidates who have experienced in Regulatory work in exporting countriesโ€
Location: Karachi
Salary: Market competitive + fringe benefits

Responsibilities:



  • Preparation & timely execution of Plan for Registration of new products and further Preparation & Technical Review of CTD/ACTD Dossiers for New Product Registration in Domestic Market / Exporting Countries.
  • Reply of Technical Queries received from DRAP / MOH of Exporting Countries during Dossier evaluation process.
  • Preparation & Technical Review of Dossiers for approval of Post Registration Variation / Changes.
  • Manage & coordinate with QA for handling Regulatory Complaints, Product Art Work, Change Control & Product Recall, etc.
  • Manage & Coordinate with the Domestic / International Marketing Team for P.h.a.r.m.a.c.o.v.i.g.i.l.a.n.c.e activities.


Skills Required:

  • Excellent communication skills both written, verbal and Computer literacy skills.
  • Good Analytical and Problem-solving skills.
  • Knowledge of prevailing Drug Laws and other regulations.

Email: personnel@atcolab.com

ATCO Laboratories Ltd Jobs Manager Regulatory Affairs

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