yle="text-align: center;">Pharmacy Lead Associate Jobs at Genpact – Apply Online
Welcome to Genpact! With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. We dream in digital, dare, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We are harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we are calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing. People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower.
Lead Associate Regulatory Affairs, Consumer CMC for Global market (LIF013456)
Lead Associate Regulatory Affairs, Consumer CMC for Global market-LIF013456
Welcome to the relentless pursuit of better.
Inviting applications for the role of Lead Associate Regulatory Affairs, Consumer CMC for Global market!
- Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
- Preparation of Quality Overall Summaries (QOS) for drug product and drug substance.
- Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
- Submission of relevant sections in Annual Reports for US Market.
- Preparing RA expert response for deficiency letters from various regulatory authorities.
- Assessment of registration documentation for consumer products as per the current Health Authority requirements.
- Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
- Post-approval submission knowledge for EU markets.
Qualifications we seek in you
B. Pharmacy / M. Pharmacy / B.Sc. / M.Sc.
Preferred Qualifications/ Skills
- Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
- 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 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 and process.
- Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
- Depending on experience level, mentor newly hired staff or lead a team of junior staff.
- Flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
Link to Original Notification to apply: Apply Here
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