Job Descriptions

• CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
• Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN.
• Review of CTD dossiers , variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
• Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
• Demonstrate subject matter and area expertise.
• Collaborate with internal and external clients,
• Supporting and enabling effective and efficient communication that results in operational excellence.
• Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.

Education & Experience

• Master’s degree in Pharma
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills And Abilities

• Excellent technical data interpretation skills
• Excellent interpersonal skills including problem solving
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of US Regulations
• Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Ability and desire to work in a team-oriented environment.

Other Requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Location Gurgaon, Haryana (INDIA)

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