Assistant Manager Regulatory Affairs in Herbion Pakistan (Pvt) Limited
- Coordinate all regulatory activities for registration of
new products.
- Responsible to prepare registration dossiers.
- Responsible to apply the renewal of PTPMA certificate.
- Prepare the reply of dossier registration queries from
any country.
- Responsible to prepare the dossier for renewal of
registered products.
- Update the renewal status of old and new products.
- Literature searching through internet, libraries and
other related sources.
- Manage timely preparation and submission of
registration dossier.
- Prepare registration documentation consistent with
appropriate regulations / guidelines.
- Assessment / vetting of registration dossier.
- Coordination of regulatory affairs department with
other departments.
- Manage specific or major projects for regulatory activities.
- Supervise and mentor junior staff members, as appropriate.
- To assist in defining regulatory strategy to meet company
objectives, in relation to both internal product and process
development (manufacturing, safety, pre-clinical) and
clinical development.
Required Skills:
- Experience of drug registration related to CIS & Eastern European countries will be given preference.
- Must be computer literate with strong communication and data management skills.
- Information of current information regarding export registration is a must.
- Must be computer literate and able to learn new software applications.
- Excellent interpersonal skills.
- Excellent communication skills in English
- Knowledge of Russian language will be an asset.
Pharmaceuticals/Clinical Research
Category:Executive Management
Total Position:1
Job Type:Permanent ( firstshift )
Job Location:Karachi
Gender:Doesn’t Matter
Minimum Education:Bachelor’s Degree
Degree Title: M. Pharm / M.B.B.S / MBA / M.D
Career Level: Manager
Required Experience: 2 Years – 5 Years
Posted:Aug 27
2009
