Regulatory Affairs (Ra) , Executive

● Process all the new dossiers till submit to DAV within the timeline.

- To prepare and compile registration dossiers as per the specific country guidelines and submit them to regulatory authorities.

- To prepare, review and compile re-registration documents.

- To prepare & review /check artwork, pack insert, SmPC etc.

- To study Regulatory guidelines of assigned countries and to prepare a checklist / template for registration dossiers.

- To verify specification of excipients, active, finished product and packaging material and all required documents.

- Application, review, coordination, follow-up of legal documents COPP, FSC etc.

● Liaise and negotiate with regulatory authorities.

● Keep up to date with changes in regulatory legislation to ensure compliance of the company.

● Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

- Maintain Proper database w.r.t to master document dossier.

- To collect and verify all technical documents and information from various departments at the manufacturing site.

- Provide Regulatory support to various departments.

- Review follow-up and coordination for registration samples /WS and impurities required for analysis purpose.

- To reply to any queries raised by the respective regulatory authority, in a timely manner.

- To maintain and update Registration certificate /information in regulatory databases.

● Develop regulatory strategies and implementation plans for the preparation and submission of new products.

● Advising and providing mandatory information related to the import of goods into the VN market.

● Follow up and resolve issues related to delivered products. Take necessary actions (submit renewal, change) to ensure products can be circulated continuously.

** More detailed job description to be discussed and given on your joining.

● More than 2 years' experience in Pharma Regulatory Affairs.

● In-depth knowledge of drug registration: Full understanding of the field of drug registration to deal with unusual and common problems.

● Full knowledge of drug development, quality control, quality assurance (related to drug registration).

● Excellent PC skills should be proficient with the usage of the internet as a tool to find necessary & useful information.

● Must be organized- timely, and with information/data.

● Fluent English skills: Communication, Reading, Writing and Translation.