Regulatory Affairs Manager

Archerchem Healthcare; Mumbai Suburban; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

Archerchem Healthcare in Mumbai seeks a Regulatory Affairs Manager to lead regulatory activities for pharmaceutical formulations in the US market. The role focuses on ensuring submissions meet US FDA requirements and ICH guidelines, and managing end-to-end regulatory lifecycle.

The ideal candidate has hands-on experience with ANDA filings, eCTD submissions, and a proven track record in US regulatory affairs.

Qualifications

• Master's degree in Pharmacy or Pharmaceutical Sciences or equivalent.
• Experience in Regulatory Affairs within the pharmaceutical formulations industry.
• Hands-on experience with US regulatory submissions (ANDA, eCTD).
• Strong knowledge of USFDA regulations and ICH guidelines.

Responsibilities

• Lead 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 guidelines.
• Coordinate with R&D, QA, QC and Manufacturing.
• Develop regulatory strategies to ensure timely product approvals and market entry.

Skills

ANDA filings

eCTD submissions

USFDA regulations

Lifecycle management

Education

Master's degree in Pharmacy / Pharmaceutical Sciences

Job description

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

Location: Malad, Mumbai
Industry: Pharmaceutical Formulations
Department: Regulatory Affairs
Position: Manager Regulatory Affairs
Regulatory Market: USA

Job Description

We are looking for an experienced and dynamic 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.