Sr. Officer Regulatory Affairs

Position: Sr. Officer Regulatory Affairs

Education: BPharm / MPharm

Experience: 3 to 5 years (Should be from formulation background only & ROW mkt )

Location : Hamlai Industries Pvt. Ltd.

AV - 25 Bol Industrial Estate, Sanand - II,

Ahmedabad, Gujarat

Job description for Regulatory Affairs candidate:

1. Responsible in preparation, review and compilation of complete dossiers as CTD or eCTD to Regulatory Authorities GCC-MENA, countries.

2. To handle Inquiries from Regulatory Authorities related to company and product registrations.

3. To ensure timelines are met for the project submissions including dossier, query response, variations, reports, renewal and all other regulatory activities.

4. Involved in Design and approval of product Artwork, SPC and PIL.

5. Assisting R&D, QA & QC departments for the preparation of documents as per Regulatory queries/ICH requirements.

6. Reviewing all technical documents like DMFs, Stability data and protocol, COAs, process validation, analytical method validation and Spec/STP, BMR & BPR as per the requirement of the dossier preparation and registration.

7. Ensuring the transfer and implementation of all the registered product information to Plant, QA, QC and customers.

8. Should be able to handle Regulatory submissions by direct coordination with the local agents through marketing team.