Regulatory Affairs Manager (ROW)

We are assisting one of our fastest-growing healthcare clients in identifying a suitable candidate for the position of Regulatory Affairs Manager.

Position: Regulatory Affairs Manager

Location: Pune

Experience: 8 to 12 years of experience in RA (ROW Singapore/Malaysia)

Job Summary

We are seeking a detail-oriented Regulatory Affairs Manager to support regulatory submissions and lifecycle management activities. The role involves coordinating with internal teams and external partners to ensure timely and compliant regulatory filings.

Key Responsibilities

• Review and compile regulatory dossiers in line with applicable guidelines and market requirements.
• Coordinate with manufacturers to request, follow up on, and track regulatory documents.
• Perform regulatory due diligence and gap assessments for new and existing products.
• Liaise with regulatory counterparts and support interactions with health authorities.
• Handle regulatory queries/deficiency letters and coordinate the preparation and submission of responses.
• Maintain and update regulatory document repositories and submission trackers.
• Support internal and external customer interactions related to regulatory requirements and timelines.
• Ensure compliance with internal SOPs and regulatory standards.
• Assist in post-approval activities and regulatory lifecycle management.

Qualifications & Skills

• Bachelors or Masters degree in Pharmacy, Life Sciences, or a related field.
• Approximately 10 years of experience in Regulatory Affairs (pharma/healthcare preferred).
• Strong understanding of CTD/eCTD dossier structure.
• Good communication, coordination, and documentation skills.
• Detail-oriented with strong follow-up and stakeholder management abilities.