RA Manager

Role & responsibilities

1. Ensure to aligned the product development and its documentation with R&D and Export Dept.

2. Submission of dossiers to overseas and Indian authorities in time for approvals

3. Submission of all approved documents either for Finished product or API to CQA and QA at various plant

4. Maintain the MIS data for each product pre and post approvals

5. Preparation & Compilation of the product Dossiers of various pharmaceutical formulations for CIS & ROW

Market.

6. Review of all technical documents (BMRs, Process Validation, Method of Analysis, Analytical Method

validation, Stability, API , FP , PM COAs & DMF etc.) recd. from Factory & follow-ups with related

departments for the same or correction/up gradation in data so as to have better compilation of dossiers.

7. Answering Queries related to Drug/ Product Registration

8. Checking of artworks as per countries requirement and submission to CQA for matter file

9. Provide Label Claim of New finished product for License application; checking of Lic. , COPP

10. Preparation of documents required for the of BE Studies

11. To co-ordinate with Q.C.,Q.A., Purchase , Production & R&D department for preparation of Dossiers of

Pharmaceutical formulations

12. Co-ordination with R&D Dept. & Support in New product development by providing all the details of new

product to R&D. Maintain Update status.

Preferred candidate profile

1. Msc/ Bpharm/Mpharm

2. experience in formulation area

3. Managerial capability to deliver

4. Hands-on with all five modules of dossier, MS-Office