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Senior Manager Regulatory Affairs

2 months ago

mumbai, India Meril 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 15 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.