Maya Singh Email & Phone Number

Pharmaceutical and Medical Device ConsultantRegulatory Affairs | Global Regulatory Compliance/Regulatory Strategy/Qualified Lead Auditor for ISO 13485Results-oriented pharmaceutical and medical device consultant with over 14 years of industry experience, specializing in regulatory affairs and quality compliance. Skilled in managing import issues, new registrations, and regulatory dossiers. Demonstrates a proven track record of successful coordination with regulatory authorities and global marketing teams. Possesses extensive knowledge of CMC and regulatory strategies and has a wealth of experience in sourcing formulations, APIs, and medical devices.Provide expert guidance and consultation to pharmaceutical, medical device, and in-vitro diagnostics companies.Liaise with the DCGI (India) office to address import-related issues and facilitate new registrations.Compile and review regulatory dossiers in various formats (CTD, eCTD, ACTD, country-specific) for submissions in the EU, Brazil, MENA, ASEAN countries, South Africa, South Korea, and Hong Kong.Coordinate with regulatory counterparts in different countries to ensure compliance throughout the approval process.Collaborate with global marketing teams to resolve registration-related issues and streamline the registration/re-registration process.Facilitate the sourcing of formulations, APIs, and medical devices for clients, ensuring high-quality products meet their requirements.Conduct ISO 13485 audits as a qualified lead auditor, ensuring compliance with quality management standards.

Listed skills include Regulatory Affairs, Regulatory Submissions, Generic Programming, Regulatory Requirements, and 14 others.