Sr. Officer Regulatory Affairs

Hamlai Industries Pvt. Ltd. ( Pharma Division); Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Hamlai Industries Pvt. Ltd. ( Pharma Division) is seeking a Sr. Officer Regulatory Affairs with 3–5 years of formulation background to manage CTD/eCTD dossiers and regulatory submissions for ROW markets from Ahmedabad, Gujarat. The role requires collaboration with R&D, QA & QC to prepare documentation.

The candidate will handle regulatory inquiries, approve artwork and PILs, and ensure timely submissions, renewals and variations in line with ICH and local regulations.

Qualifications

• Experience in regulatory submissions for formulation products.
• Familiar with CTD/eCTD dossier compilation and GCC-MENA requirements.
• Coordination with R&D, QA & QC for regulatory documentation.
• Ability to manage submission timelines and inquiries from authorities.

Responsibilities

• Prepare, review and compile CTD/eCTD dossiers for regulatory authorities.
• Handle inquiries related to product registrations from authorities.
• Ensure timelines for submissions, variations and renewals are met.
• Design and approve product artwork, SPC and PIL.
• Assist R&D, QA & QC with regulatory documents per ICH requirements.
• Review DMFs, stability data, COAs, process/analytical validation docs.
• Transfer registered product information to Plant, QA, QC and customers.
• Coordinate regulatory submissions with local agents via marketing team.

Skills

Regulatory affairs

Dossier preparation

CTD/eCTD

Timeline management

Interdepartmental coordination

Education

BPharm / MPharm

Job description

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.