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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 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.