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 Years’ 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 countries”
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: [email protected]
