Key Responsibilities

- Preparation and submission of dossiers for India (CDSCO/FDA) and ROW markets
- Handling product registrations, renewals, and variations
- Coordination with internal teams (F&D;, QA, Production) for OSD products
- Managing regulatory documentation for third-party products (injectables & syrups)
- Follow-up and response to regulatory queries
- Review of artwork, labels, and pack inserts as per regulatory requirements
- Coordination with CMOs for document collection and compliance alignment
- Keeping track of regulatory updates and implementing changes

Candidate Profile

- Experience: 8 +.years experience in Regulatory Affairs

- Qualification: B.Pharm / M.Pharm.(Regulatory/Pharmaceutics preferred)

- Experience in handling multiple dosage forms will be preferred

- Exposure to ROW markets is required

Key Skills





- Dossier preparation & compilation (CTD/ACTD)

- Strong coordination and follow-up skills

- Positive understanding of regulatory requirements (India & ROW)
- Ability to handle work independently in a dynamic setup

- Good understanding of cGMP and pharmaceutical manufacturing processes.

- Exposure to PICS and regulatory audits.

Mandatory Requirements

- Must have hands-on experience in domestic regulatory affairs as well.
- Plant visit is mandatory (monthly or as required).
- Experience in handling PICS and other regulatory audits.
- Hands-on approach (not just documentation)
- Ability to manage multiple projects at a time
- Ownership of regulatory activities end-to-end

📌 Regulatory Affairs (Mumbai)
🏢 Tulip Lab
📍 Mumbai