Regulatory Affairs Manager

Centaur Pharmaceuticals; Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Centaur Pharmaceuticals seeks a Sr. Manager with 12+ years in Regulatory Affairs for EU and international markets such as Australia, Canada, New Zealand, and South Africa. The role focuses on authoring CMC documentation, regulatory strategy, and agency interactions.

You will coordinate cross-functional teams for timely submissions, ensure regulatory compliance across the product lifecycle, and maintain up-to-date knowledge of evolving guidelines. Mumbai-based leadership role with global scope.

Qualifications

• 12+ years of experience in Regulatory Affairs for EU and other international markets
• Expertise in authoring and reviewing CMC documentation for pre- and post-approval submissions
• Hands-on experience with eCTD software for EU and other markets such as Australia, Canada, New Zealand, South Africa
• Strong ability to develop regulatory strategies across product lifecycles and manage agency interactions

Responsibilities

• Author and review CMC documentation for regulatory submissions
• Develop and execute regulatory strategies across the product lifecycle
• Coordinate with internal and external stakeholders for effective submissions
• Guide the team on regulatory filings and lifecycle management
• Keep up-to-date with regulatory guidelines
• Assess change control documents and classify change categories
• Manage administration of regulatory documentation and ensure traceability of regulatory history

Skills

Regulatory Affairs

EU submissions

eCTD software

Agency interactions

Product lifecycle

Education

M.Pharm

B.Pharm

M.Sc.

Tools

eCTD Software

Job description

Position: Sr. Manager M.Pharm/B.Pharm/M.Sc. having 12+ years’ experience in Regulatory Affairs for EU and other international markets such as Australia, Health Canada, New Zealand, South Africa

1. Expertise in authoring, reviewing CMC documentation for pre and post-approval submissions with hands‑on experience on using eCTD software for EU and extension to other international markets such as Australia, Canada, New Zealand, South Africa
2. Accountable for developing and executing regulatory strategies across the product lifecycle and managing effective agency interactions
3. Responsible for providing support and regulatory guidance to team in the completion of projects supporting regulatory filings.
4. Responsible for Product life cycle management
5. Co-ordination with internal & external stakeholders for effective submissions
6. Keep knowledge up to date about regulatory guidelines
7. Assessment of change control documents and provide accurate assessment of the change category
8. Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc)