Manager - Regulatory Affairs
- Genpact India
- 4 to 6 Yrs
- Mumbai
- 3 years ago
- Email to a friend
- Report this job
Job Description
*With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world s biggest brands and we have fun doing it. Now, we re calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us.
Are you the one we are looking for
We are inviting applications for the role of Manager, Regulatory affairs In this role, you will be responsible to work on deadlines, in a fairly high pressure business environment while being a good team member. You should have the ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
Responsibilities
The Role demands for a highly qualified professional who should have experience under regulatory affairs domain. Lead Associate will be responsible for all the activities related to
Responsible for providing Regulatory filing support (Ancillary Documents) by reviewing compiled submissions.
Assessing the requirements for ancillary document based on HA needs
Should have hand on experience on Legalization/Apostilization/Notary as and when required.
Experience in Data Management System (Vevva) or any type of Document Management system
Should aware of administrative documents like CPP, GMP Manufacturing license.
Prior experience compiling CMC ancillaries in support of variations, renewals &/or annual reports a plus.
Minimum Qualifications
Bachelor s degree in pharma / Science
Strong financial analytical skills and prioritisation skills.
Effective communicate in writing and verbally to senior management.
Experience in balancing customer facing role and work assessments.
Demonstrated proficiency in advanced document management system.
Ability to generate innovative solutions to issues and optimally work with and communicate to key partners.
Preferred qualifications
Able to further working relationships with the team, peers and clients, scheduling flexibility required
Overall candidate should have decision-making, research and analytics approach and in numbers.
Good people and customer handling skills.
Effective communication and interpersonal skill.
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com . Follow us on Twitter, Facebook, LinkedIn, and YouTube.
,Employement Category:
Employement Type: Full timeIndustry: IT - Software
Role Category: IT Operations / EDP / MIS
Functional Area: Not Applicable
Role/Responsibilies: Manager - Regulatory Affairs
Contact Details:
Company: Genpact IndiaLocation(s): Mumbai
Similar positions
Genpact India
Genpact (NYSE: G) is a global professional services firm focused on delivering digital transformation for our clients, putting digital and data to work to create competitive advantage. We do this by integrating lean principles, design thinking, analytics and digital technologies with our domain and ...
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in
