Genpact is a global professional services firm that makes business transformation real. We drive digital-led innovation and digitally-enabled intelligent operations for our clients, guided by our experience running thousands of processes primarily for Global Fortune 500 companies.
Post : CMC Professionals – Regulatory affairs
Qualification : B.Sc in Any Specialization,B.Pharma in Any Specialization-from 4 to 9 year(s) of Experience
Salary : Rs 4,00,000 – 8,00,000 P.A.A
Job Description : Hiring For CMC Professionals – Regulatory affairs in Genpact
Work Location : Mumbai
Shifts : US Shifts (5.30 pm on wards)
Responsibilities
• Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
• Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Deliver all regulatory results for assigned products across the product lifecycle
• Identify and communicate potential regulatory issues to GRACS CMC, as needed
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Demonstrated effective leadership, communication, and interpersonal skills.
Interested candidates can share their resumes with me on srishti.sethi1@genpact.com
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