Job Description
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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 Assistant 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- Work closely with various stakeholders to ensure the timely completion of submission assemblies that adhere to regulatory health authority guidelines for electronic/hardcopy submissions.
- The incumbent will support global process; executing end-to-end submission assembly which includes publishing, quality control verification, finalization and delivery.
- This requires collaborative interaction with component providers and submission managers to ensure quality, right first time output and timeliness.
QualificationsMinimum Qualifications- Regulatory publishing experience or Bachelor s degree with regulatory publishing experience.
- Expertise with the Liquent InSight Publisher application.
- Expertise with industry standard electronic document management system.
- In depth working knowledge of industry standard publishing systems and desktop applications including MS Word and Adobe Acrobat Professional.
- Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
- Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviours to drive high quality deliverables.
- Demonstrates the ability to independently solve complex problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions.
- Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation.
Preferred qualifications- 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.
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Employement Category:
Employement Type: Full time
Industry: BPO / Call Center
Role Category: Sales / BD
Functional Area: Not Applicable
Role/Responsibilies: Assistant Manager - Regulatory affairs
Contact Details:
Company: Genpact India
Location(s): Mumbai