Samarth Life Sciences Hiring RA Professionals (2-5 yrs) @Goregaon Mumbai

Experience required for the Job:

2 - 5 years

Website:- https://samarthlife.com/

Location- Goregaon (Mumbai)

Job Profile & Role Purpose :

1. Preparation and submission of dossiers as per countries assigned. 2. Review of Process Validation, Product development records, BMR,BPR,Stability data, Certificate of Analysis etc.required for dossiers.

3.FDA related work- Application of COPP, Legalization of Documents through different embassies, Loan License documentation etc.

4. Co-ordinate with departments such as Manufacturing,Product Development,QA/QC,R&D, Legal,Purchase etc. to ensure availability of documents and samples for submission.

5. To check & review Art-works, Labels, and Pack-inserts.

6. Response of queries and other requirements as required by respective regulatory authorities in a stipulated time frame.

Key Accountabilities :

1. Keeping abreast of international legislations, guidelines and customer practices in all countries that the company is exporting to.

2. Keeping up-to-date with changes in regulatory environment in the home country and countries of operation.

3. Maintaining Country-wise database of registration status and updating Marketing team periodically.

SAMARTH LIFE SCIENCES PVT. LTD. Himavant Singh E-mail: himavant.singh@samarthlife.com