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Job Description
- Establish and develop the regulatory process in different export markets, and ensure adequate registration steps and procedures in new as well as established market.
- Prepare all Export Registration dossiers for different countries and prepares dossiers for Re-registered products.
- Prepare and follow up the company registration process to invade new and different markets.
- Follow up all steps of export registration with agents authorized from chemipharm and Ministry Of Health of different countries including Stability Study, Bioequivalence Study, Inserts, Packs, Analysis and pricing.
- Follow up any change needed in any product such as change in pack, formula or name to facilitate the registration process in different countries.
- Establish and maintain good relationship with the internal and external stakeholders.
- Coordinate with the R&D, Q.C, Production, and Marketing team members regarding the different registration issues.
- Ensure all registration activities are in compliance with chemipharm and National laws & regulations.
- Ensure confidentiality in respect of registration files contents.
- Review carefully compiled files to ensure that content, quality; accuracy and format of submission comply with applicable regulations of the different market.
- Develop and maintain registration track record for the market.
- Implement and ensure sustainability of each SOP per function.
- Expert in preparing CTD files
Job Requirements
- Bachelor Degree in Pharmaceutical Sciences
- Background knowledge of regulatory applications and procedures.
- Excellent English, verbal / written communication.
- Excellent computer skills.
- Interpersonal & communication skills.
- Careful planning to achieve accurate and timely results.
