Manager - Regulatory affairs
- Genpact India
- 4 to 6 Yrs
- Mumbai
- 5 years ago
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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 are encouraged to be responsible for building various offerings in business insight area as requested by the clients on a regular basis. The individual must be an active contributor towards the overall objective of the project. We are looking for some who should be open to work in any shift as per the business requirement.
Responsibilities- Responsible to provide regulatory filing support for assigned Submissions by:
- Providing required submission activities [planning, obtaining required data (CMC/ancillary documents), coordination, reviewing, and release] in accordance to regulatory requirements and project timelines.
- Responding to health authority questions or local subsidiary requests for additional information to support the Submission.
- Project Management expertise.
- Understanding of regulatory requirements.
- Excellent organizational skills and a proven ability to multi-task.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Demonstrated proficiency in advanced document management system.
- Superior attentiveness to detail.
- Ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
- Flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
- Effective leadership, communication, and interpersonal skills.
- Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed.
- Ability to identify problems and work with team to formulate a potential course of action.
- Knowledge on Pharmacy/Science
- Able to nurture robust working relationships with the team, peers and clients, scheduling flexibility required
- Overall candidate should have problem solving, macro-level research and analytics approach and good 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 - SoftwareRole Category: IT Operations / EDP / MISFunctional Area: Not ApplicableRole/Responsibilies: Manager - Regulatory affairsContact Details:
Company: Genpact IndiaLocation(s): Mumbai
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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 ...
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