Genpact is Hiring in Regulatory Affairs and has issued notification to accept Applications. Genpact (NYSE: G) 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..Application form link provided at the end of post. Eligibility for the Head/VP/GM-Regulatory Affairs as follows.
Vacancy summary details :
- Company Name: Genpact
- Location : Mumbai
- Post Name: Head/VP/GM-Regulatory Affairs
- Qualification: Bachelor’s degree in pharma / Science
- Experience: 4 to 9 years
- No of Vacancies: Not Disclosed by Recruiter
- Details of Salary: 4,00,000 – 8,00,000 P.A.
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process ( Personal interview , Group discussion , etc…,)
- Contact: firstname.lastname@example.org
Job Description/Skills Required:
- 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.