Genpact Biological Sciences Associate Job – Apply Online
Genpact Biological Sciences Associate Job – Apply Online. BSc Biological Sciences Lead Associate, Regulatory Affairs-LIF012814 job opening at Genpact. Genpact Mumbai BSc Life Sciences Job. Interested and eligible applicants can check out all of the details on the same below
Possible Interview Questions May be asked for Lead Associate, Regulatory Affairs-LIF012814 at Genpact are posted below
Lead Associate, Regulatory Affairs-LIF012814
Primary Location: India-Mumbai
Schedule: Full-time
Education: Level Bachelor’s / Graduation / Equivalent
Un posting: Date Ongoing
Master Skills: List Operations
Job Category: Full Time
Job Description for Lead Associate-Submission Publisher at Genpact:
With a start-up 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 in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re 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’re 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. Welcome to the relentless pursuit of better.We are inviting applications for the role of Lead Associate, Regulatory Affairs
You will be responsible for managing all the activities involved in planning, and dispatching US Annual Reports.
Responsibilities:
- The Annual Report Submission Planner is responsible to provide regulatory filing support for assigned Annual Report by providing required submission activities (planning, obtaining required data (CMC/ancillary documents), coordination, reviewing, and release) in accordance to regulatory requirements and timelines.
- Respond to health authority questions or local subsidiary requests for additional information to support the Annual Reports.
- Administrative Content (Module 1) preparation for Annual Reports-US market.
- To handle Regulatory document management systems: ORION -COGNOS, VEEVA, REDS, SPARS etc.
- Coordination with clients in tracking and status update of project plans.
- Ensure a timely submission of Annual Reports to the agency.
- Coordination team review, electronic content publishing, and release of the Annual Report submission content.
- Willing to work for US Shift
Qualifications we seek in you!
- Bachelor’s or master’s degree (or other advanced degree) preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline requirement.
- Bachelor’s degree preferably in Pharmacy, Biological Science, Chemistry, Nursing, or related discipline required with at least 4 years of related experience in the pharmaceutical industry. Alternatively, a master’s or other advanced degree with relevant experience in pharmaceutical industry.
- Excellent organizational skills and a proven ability to multi task.
- Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
- Demonstrated understanding of related fields (e.g., Pharmaceutical manufacturing, analytical testing, and quality assurance.) Demonstrated proficiency in RCAM or advanced document control system. Superior attentiveness to details.
- Ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
- Flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to handle multiple priorities and balance work to achieve business goals.
- Effective leadership, communication and interpersonal skills.
- Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed.
- Ability to identify problems and work with team to formulate a potential course of action.
Preferred Skills
- Demonstrated understanding of regulatory affairs and pharmaceutical registrations
- Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Capability to prioritize multiple priorities and balance work to achieve business goals.
- Demonstrated effective leadership, communication, and interpersonal skills.
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
Possible Interview Questions May be asked for Lead Associate, Regulatory Affairs-LIF012814 at Genpact
- Question: Can you explain the role and responsibilities of a Lead Associate, Regulatory Affairs in the context of managing US Annual Reports submissions? Answer: A Lead Associate, Regulatory Affairs is responsible for coordinating and managing activities related to planning, coordinating, reviewing, and releasing US Annual Reports submissions. This includes ensuring compliance with regulatory requirements, responding to health authority queries, preparing administrative content, and utilizing regulatory document management systems.
- Question: How would you handle a situation where a health authority raises questions or requests additional information to support an Annual Report submission? Answer: In such a scenario, I would promptly review the specific queries or requests from the health authority and collaborate with relevant stakeholders to gather the necessary information. I would ensure that the response is thorough, accurate, and complies with regulatory guidelines. Effective communication and coordination are key to addressing these requests in a timely and satisfactory manner.
- Question: Can you elaborate on your experience with regulatory document management systems such as ORION-COGNOS, VEEVA, REDS, and SPARS? Answer: I have hands-on experience with regulatory document management systems, particularly ORION-COGNOS, VEEVA, REDS, and SPARS. I am proficient in utilizing these systems to manage and organize regulatory documents, track project progress, and ensure timely submissions. These systems play a crucial role in maintaining compliance and facilitating efficient communication within the regulatory affairs process.
- Question: How do you ensure the timely submission of Annual Reports to regulatory agencies while maintaining accuracy and quality? Answer: Timely submission of Annual Reports is achieved through effective planning, coordination, and attention to detail. I would establish a well-defined submission timeline, allocate tasks, and closely monitor progress. Regular communication with team members and clients ensures that required data is obtained, reviewed, and released within regulatory timelines. Rigorous quality checks and adherence to regulatory guidelines guarantee accurate and high-quality submissions.
- Question: Can you provide an example of a situation where you had to prioritize multiple tasks and balance work to achieve business goals in a regulatory affairs context? Answer: In my previous role, I was responsible for managing multiple regulatory submissions simultaneously. One instance involved coordinating the submission of two different product registrations with overlapping timelines. To balance the workload, I assigned specific tasks to team members based on their expertise, closely monitored progress, and ensured that each submission met regulatory requirements. Effective prioritization and collaboration resulted in successful and timely submissions for both products.
These questions aim to assess the candidate’s understanding of regulatory affairs, experience with submission processes, organizational skills, and ability to handle challenges in the pharmaceutical industry. The provided answers demonstrate the candidate’s knowledge, skills, and approach to handling various aspects of the Lead Associate role.
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