Senior DRA Associate At Novartis | Pharmacists Vacancy |3-5 years’ experience in regulatory affairs
Job Summary:The registration of new products and the re-registration of Bio, Onco & Retail products in order to ensure viability of these products in the marketplace.
Major Accountabilities:Prepare & submit drug registration files in a timely manner.
Follow up of the files with MOH officials to achieve a favorable outcome.
Get the registration & re-registration approvals in due time.
Develop and maintain good working relationships with other stakeholders both locally and with HQ and with health authority.
Package insert update and new indications approvals in due dates.
Post registration variations submission & approval in due dates according to marketing plans/ Global guidelines.
Assist Drug Regulatory Affairs Head in maintaining & improving strong MOH relationships through Attending/participating/contributing
Medical background (Pharmacists)
3-5 years’ experience as an associate in regulatory affairs dealing with a wide variety of registration projects and issues.
Strong communication, negotiating skills, willing to learn and teamwork skills.
Fluency in English both verbal and written, efficient Computer Skills.
Thorough attention to details and high standards of accuracy.
Good understanding for EDA regulations, requirements & Guidelines.
COMMERCIAL OPS SIR SZ
Research & Development