Genpact Pharma Technical Associate Job Opening – Apply Online
Genpact Pharma Technical Associate Job Opening – Apply Online. MSc Pharma Jobs. Interested and eligible applicants can check out all of the details on the same below
JOB TITLE :Technical Associate – Regulatory Affairs (LIF012333)
Primary Location : India-Mumbai
Schedule : Full-time
Education Level : Bachelor’s / Graduation / Equivalent
Master Skills List : Operations
Job Category : Full Time
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.
Inviting applications for the role of Technical Associate
In this role candidates should have experience in regulatory affairs while essential exposure to the lifecycle document management (LCM) and need to have good knowledge of ICH guidelines and post-approval submissions and regulations.
Responsibilities:
- 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 products and drug substances.
- 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!
Minimum Qualifications: 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 troubleshoot 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.
Possible Interview Questions for the role of Technical Associate – Regulatory Affairs at Genpact:
- Can you explain your understanding of regulatory affairs and its importance in the pharmaceutical industry? Answer: Regulatory affairs in the pharmaceutical industry involves ensuring compliance with regulatory guidelines and laws related to the development, registration, and commercialization of pharmaceutical products. It plays a critical role in ensuring product safety, efficacy, and quality. Regulatory affairs professionals collaborate with cross-functional teams to compile and submit regulatory submissions, interact with regulatory authorities, and provide strategic guidance to ensure compliance throughout the product lifecycle.
- What experience do you have in handling regulatory submissions and documentation? Answer: In my previous role as a regulatory affairs intern, I had the opportunity to work on compiling and submitting regulatory submissions for new drug applications (NDAs), investigational new drug (IND) applications, and variations. I have experience in preparing documentation such as regulatory dossiers, technical reports, and labeling updates in accordance with regulatory requirements. I am familiar with document management systems and have a keen eye for detail when it comes to accuracy and completeness of regulatory documents.
- How do you stay updated with the evolving regulatory landscape and changes in regulations? Answer: Staying updated with regulatory changes is crucial in the pharmaceutical industry. I make it a point to regularly review regulatory guidelines, attend industry conferences, and participate in professional development programs related to regulatory affairs. I also subscribe to regulatory newsletters and follow reputable regulatory authorities’ websites to ensure I am aware of any new guidelines, policies, or regulatory updates that may impact our products or processes.
- Can you provide an example of a challenging regulatory issue you have encountered in the past and how you resolved it? Answer: In my previous role, we faced a complex labeling issue where the requirements of two different regulatory agencies contradicted each other. To resolve this, I conducted thorough research, consulted with regulatory experts, and engaged in discussions with internal stakeholders and regulatory authorities. After careful evaluation, we proposed a solution that met the requirements of both agencies while ensuring patient safety and compliance. The resolution involved revising the labeling content and implementing a clear and comprehensive communication strategy to inform relevant stakeholders of the changes.
- How do you prioritize and manage multiple projects and deadlines in a regulatory affairs role? Answer: Effective project management is essential in regulatory affairs to meet deadlines and ensure timely regulatory submissions. I utilize project management tools and techniques such as creating project plans, establishing clear milestones, and regularly monitoring progress. I prioritize tasks based on their urgency, regulatory impact, and cross-functional dependencies. I am proactive in communicating with internal teams to align on timelines and resource allocation, and I adapt my approach as needed to address shifting priorities and manage time efficiently.
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