Genpact Pharmaceutical Sciences Job – Technical Associate Regulatory Affairs
Genpact Pharmaceutical Sciences Job – Technical Associate Regulatory Affairs. 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.
Job: Technical Associate – Regulatory Affairs-CPG023985
Primary Location: India-Mumbai
Education Level: Bachelor’s / Graduation / Equivalent
Job Posting: Jun 25, 2021, 4:18:31 PM
Unposting Date: Ongoing
Master Skills List: Operations
Job Category: Full Time
Responsibilities
- Conduct hurdle meetings on daily basis.
- To ensure the quality of authoring of change summary and review of Annual report compilation.
- Conduct meetings with MSD External partners to support compliant execution of change management and overall annual report compilation with an unwavering focus on regulatory conformance.
- Assess and communicate potential regulatory risks and propose mitigation strategies.
- Deliver all regulatory milestones for the assigned product as pre-defined timeliness
- Communicate any discrepancies related to product/ documents or system to Product lead / SME and seek clarification/confirmation as applicable.
- Identify, communicate and escalate the potential regulatory issue to GRACS CMC management, as needed.
- Prepare Weekly status deck for all internal and external stakeholders for Vaccines Annual report as applicable.
Qualifications we seek in you!
Minimum qualifications
- Masters in pharmaceutical sciences
- Rich experience in the pharmaceutical industry involving generic drugs registration, life cycle management, post approvals, supplement, amendments, annual report compilation and submission, approvals of change controls, Drugs Labelling and SPR submission of US Europe and Australia Market as applicable, and communication with Health authorities as per requirement.
Preferred qualifications
- Effective time management and organizational skills
- Effectively communication
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