Lead Associate - Regulatory Affairs
- Genpact India
- 0 to 5 Yrs
- Mumbai
- 5 years ago
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Job Description
Lead Associate, Regulatory affairs In this role, you will be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products Responsibilities The Role demands for a highly qualified professional who can provide mentorship to direct reports typically comprising of first line managers and supervisors. 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: IT - SoftwareRole Category: Sales / BDFunctional Area: Not ApplicableRole/Responsibilies: Lead Associate - Regulatory AffairsContact Details:
Company: Genpact IndiaLocation(s): Mumbai+ View Contact
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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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