Lead consultant - Regulatory Affairs
- Genpact India
- 4 to 6 Yrs
- Mumbai
- 3 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 Lead Consultant, Regulatory Affairs In this role, you are expected to have good knowledge of Planning and timely execution of product life cycle management projects. We are looking for some who should be open to work in any shift as per the business requirement. Responsibilities The Role demands for a highly qualified professional who can provide guidance to direct reports typically comprising of first line managers and supervisors. Senior Manager will be responsible for all the activities related to- Perform document level & submission level publishing, assembly and distribution activities.
- Performing submission readiness checks.
- Compiling SAS and other datasets and non-PDF files.
- Publishing documents for eCTD, NeeS, paper, and other PDF format submissions.
- Performing final technical quality review and technical validation (eCTD/NeeS)
- In depth solid understanding of ECTD/ NEES types of submission, industry standard publishing systems.
- Effective time management and interpersonal skills to efficiently run 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 behaviors to drive high quality deliverables
- Demonstrates the ability to independently solve trouble shoot 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
- Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
- Bachelor s degree in pharma / Science
- Strong financial analytical skills and problem solving skills.
- Effective communicate in writing and verbally to senior management.
- Experience in balancing customer facing role and work assessments.
- Self-starter and have analytical, problem solving skills
- Ability to balance customer governance meetings
- 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.
Employement Category:
Employement Type: Full timeIndustry: BPO / Call Center
Role Category: R&D / Product Design
Functional Area: Not Applicable
Role/Responsibilies: Lead consultant - Regulatory Affairs
Contact 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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