Senior Manager Regulatory Affairs Job at Mumbai, Maharashtra, India Full Time

We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team.

Positions are: Senior Manager Regulatory Affairs

Experience: 11 to 16 years

Location: Andheri east, Mumbai

Working Days: 6 days (Mon-Sat) – WFO

Responsibilities

• Lead regional team to ensure medical device product approval.
• Support team in handling queries and liaise with Health Ministries for approvals.
• Coordinate with internal teams, R&D, and QA/RA for dossier submissions and approvals.
• Communicate with global distributors/consultants for device approvals.
• Coordinate with International Sales Team for country-specific registrations.
• Maintain and update submission documentation and records.
• Manage QMS documentation and prepare for audits per country requirements.
• Handle change control and variation filings for registered products.
• Manage regulatory budgets for the assigned region.
• Ensure data management as per departmental standards.

Qualifications

• Master’s degree (M.Pharm, MS, MBA) or a Ph.D. in regulatory affairs, pharmaceutical sciences, clinical research, or a related field can be highly advantageous.
• Microsoft Office (Outlook, Excel, Word, PowerPoint, etc.) Organized
• Strong leadership skills.