Regulatory Affairs Consultant
Aspen Healthcare
مجموع سنوات الخبرة :14 years, 1 أشهر
Prepared and submitted the Registration dossiers and other formalities to regulatory authorities for all Abela Freres s.a.l portfolio including GlaxoSmithKline, Schering Plough, Nutricia, Baxter Oncology, Meda Pharma, Yves Ponroy .
Coordinated directly with the regulatory authorities' responsible in order to ensure timely approvals and fast resolution of any issues.
Ensured direct to the point and clear communications with the suppliers to assure that the documentations are compliant with the law details and accordingly allow timely files 'submission.
Continuously followed up with the suppliers to apply for any necessary files updates in compliance with the authority's laws and recommendations.
Maintained updated files and documentations for all licensed products to facilitate tracking the regulatory status of any product.
Retained up to date knowledge of relevant regulatory formalities and advised colleagues & Management of implications of any changes taking place.
Assisted in establishing good and effective liaison with regulatory authorities and the suppliers.
Followed up on the Ministry of Health annual tender contract.
Prepared analytical reports related to local market's situations and customers' needs.
Worked on team basis.
Acquired excellent selling and negotiation skills.
Achieved sales targets.
Accomplished regular calls to active and prospect customers.
Organized round tables and seminars with the key doctors in the area.
Accomplished regular calls to active and prospect customers.
Managed doctor's needs and maintained their contentment.
Handled feedback reports on a daily and weekly basis.
Handled objections by: accepting, giving value, qualifying, isolating, and closing.
Monitored competitor's activities in the market.