Regulatory Affairs Executive

2 years

0 Lacs

Posted:1 day ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

We Are Hiring – Regulatory Affairs Executive (0–2 Years)

Location:

Department:

Salary:


Regulatory Affairs Executive

🔹 Key Responsibilities

CTD/ACTD dossiers

• Handle authority queries and ensure timely submission of responses

• Review packaging artworks and coordinate final approvals

• Collect & compile regulatory data (Q&Q, COAs, COPPs, stability, FPS/FPMOA, procedures)

• Coordinate with QA, QC, Production, Packaging & Development teams

• Arrange product samples and standards for registrations/renewals

• Coordinate with Licensing for COPP, FSC, and administrative documents

• Maintain regulatory trackers and ensure documentation compliance

• Stay updated with CDSCO/WHO/FDA/EMA/MOH guidelines

• Support in audits, GMP documentation & client/authority queries

🔹 Skills & Competencies

CTD/ACTD

• Strong documentation & communication skills

• MS Office proficiency (Excel/Word/PPT)

• Attention to detail and ability to meet timelines

• Positive attitude, analytical mindset & teamwork abilities

📩 How to Apply

Interested candidates can send their updated resume to: hr@ambixhealthcare.com

Join us and be a part of a dynamic and growing regulatory team!

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