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Job Description
- Fulfill registration & Re- Registration/ variations / inquiries of company products throughout their registration life cycles including preparation files CTD /eCTD files format and submission of regulatory documentation to different authorities in different countries within the specified time frame.
- Contact with Export Certificates Department in CAPA to issue all required Export Certificates e.g.: CPP, free sale and price certificate.
- Negotiation and effective communication with agents to obtain timely product approval.
- Expertise proficiency with software tools and metrics for CTD / ECTD submission.
- Follow up with Bio-equivalence center to obtain required study with health authority specification.
- Contacting with other departments inside company to collect documents needed for registration files submission (R&D, Q.C., Marketing, and Medical Department) such as composition forms COAS, analytical procedures, stability studies, insert leaflets, pricing approvals, etc.
- Strictly following all the authority regulations, decisions & decrees.
- Follow up production of 1st production Batch for Export countries.
- Prepares the responses to authorities in a timeouts manner.
- Keep abreast of new developments in legislation, guidelines and recommendations of the various Health Authorities.
- Provide guidance and feedback to regulatory affairs management.
Job Requirements
- BSC Pharmacist, Vet & Science
- Very good commend in English
- 3 to 5 years’ experience
- Ability to communicate with others and solve problems
- Has the skill to negotiate and work collectively Basic selling skills and negotiation skill
