Specialist – Regulatory Affairs Position at Genpact in Mumbai
A rare chance has emerged for candidates in the field of regulatory affairs. Genpact is inviting applications for the Genpact Regulatory Affairs Job, a Specialist – Regulatory Affairs position in Mumbai, Maharashtra, India. This role is pivotal in shaping the future of work through advanced technology and regulatory strategies.
About the Company
Genpact is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. With a focus on AI and digital innovation, Genpact helps companies across various industries to enhance their operational excellence and achieve sustainable growth. The company is headquartered in New York, USA, and operates with a commitment to fostering a culture of curiosity, courage, and innovation.
Job Details:
- Company: Genpact
- Position: Specialist – Regulatory Affairs
- Location: Mumbai, Maharashtra, India
Regulatory Affairs Specialist Role Description
The Specialist – Regulatory Affairs in this Genpact Regulatory Affairs Job will be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations. This role involves preparing and reviewing information necessary for the development of regulatory CMC dossiers for both small and large molecules. The candidate will work closely with cross-functional teams to ensure compliance and effective communication throughout the project lifecycle.
Key Responsibilities
- Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products.
- Author CMC documentation for worldwide marketing of pharmaceutical products.
- Review scientific information to assess technical merits and suitability.
- Prioritize and execute projects according to timelines and schedules.
- Coordinate with cross-functional teams on project status and documentation.
- Understand job responsibilities and processes of related departments.
- Utilize RA/QA/QC systems and tools effectively.
- Participate in departmental improvement activities and maintain standard operating procedures.
Eligibility Criteria
- Experience in regulatory affairs, quality assurance, or quality control.
- Strong oral and written communication skills.
- Ability to generate innovative solutions and collaborate with stakeholders.
- Advanced knowledge of MS Office.
- Attention to detail and flexibility in responding to changing priorities.
Why Join Genpact?
Genpact offers a unique opportunity to be a transformation leader at the forefront of AI automation and digital innovation. Employees can make a significant impact by driving change for global enterprises and solving critical business challenges. The organization provides hands-on experience, mentorship, and continuous learning opportunities, all within a values-driven culture that emphasizes integrity and inclusion.
How to Apply for This Regulatory Affairs Specialist Role
Conclusion
The Genpact Regulatory Affairs Job is a significant step for qualified candidates looking to advance their careers in a dynamic environment. Interested individuals are encouraged to apply at the earliest to seize this chance to contribute to innovative solutions in the pharmaceutical industry.
