Hiring: Regulatory Affairs Manager - US Market (Pharma Formulations)

Location: Malad, Mumbai

Industry: Pharmaceutical Formulations

Department: Regulatory Affairs

Position: Manager Regulatory Affairs

Regulatory Market: USA

We are looking for an experienced and energetic Regulatory Affairs Manager to lead and manage regulatory activities for pharmaceutical formulations in the US market.

The ideal candidate should have strong hands-on experience in ANDA filings, eCTD submissions, USFDA regulatory requirements and end-to-end regulatory lifecycle management.

Key Responsibilities

- Lead and manage regulatory submissions for pharmaceutical formulations in the US market.
- Prepare, review, compile and manage ANDA and eCTD regulatory dossiers.
- Handle regulatory submissions to the USFDA.
- Ensure compliance with USFDA, ICH and applicable international regulatory guidelines.
- Coordinate with cross-functional teams including R&D;, QA, QC and Manufacturing.
- Manage product registrations, variations, renewals and regulatory lifecycle activities.




- Review regulatory documentation and ensure accurate and timely submissions.
- Monitor USFDA regulatory updates and assess their impact on existing and upcoming products.
- Coordinate with US-based clients, consultants and regulatory agencies.
- Develop regulatory strategies to ensure timely product approvals and market entry.

Candidate Profile

- Master's degree in Pharmacy / Pharmaceutical Sciences or equivalent qualification.
- Relevant experience in Regulatory Affairs within the pharmaceutical formulations industry.
- Strong hands-on experience in the US regulatory market.
- Practical knowledge of ANDA filings and eCTD submissions.
- Good understanding of USFDA regulations and ICH guidelines.
- Experience in dossier preparation, regulatory documentation and submission management.
- Excellent communication, documentation and stakeholder management skills.

Interested candidates can share their updated CV at [email protected] or whats up on (phone hidden).

📌 Regulatory Affairs Manager (Mumbai)
🏢 Archerchem Healthcare
📍 Mumbai