Latest role for Associate RA position at Genpact, Interested and eligible candidates can check out all the details in the same below.
Job title: Lead Associate, Regulatory Affairs
Job Location: India-Mumbai
Education Level: Bachelor’s / Graduation / Equivalent
Master Skill: List Operations
Job Category: Full Time
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
Responsibilities for Associate RA position at Genpact:
- 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 for Associate RA position at Genpact!
- 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.
- 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.
Possible interview question may be asked for Associate RA position at Genpact
1.Can you describe your experience in the pharmaceutical industry and how it aligns with the requirements of this Lead Associate, Regulatory Affairs role?
Answer: Certainly! I hold a Bachelor’s degree in Pharmacy, and over the past four years, I have gained valuable experience working in the pharmaceutical industry. During this time, I have been actively involved in regulatory affairs and have successfully managed the preparation and submission of Annual Reports for the US market. My understanding of pharmaceutical manufacturing, analytical testing, and quality assurance has allowed me to ensure compliance with regulatory requirements and maintain a keen eye for details in document management. Additionally, I have effectively communicated with key stakeholders to address regulatory issues in a succinct and logical manner, demonstrating my strong oral and written communication skills. My background and expertise align well with the responsibilities of the Lead Associate, Regulatory Affairs position, making me well-suited for this role.
2. As a Lead Associate in Regulatory Affairs, how do you ensure that you stay up-to-date with changing regulations and industry trends?
Answer: Staying updated with changing regulations and industry trends is essential in regulatory affairs. To achieve this, I regularly engage in professional development opportunities such as attending regulatory conferences, workshops, and webinars. I also subscribe to relevant publications and newsletters to keep abreast of the latest developments in the pharmaceutical industry. Additionally, I actively participate in internal knowledge-sharing sessions with cross-functional teams to exchange insights and best practices. By continuously learning and staying informed, I ensure that our organization complies with the latest regulatory requirements and operates with the most current industry knowledge.
3. In the pharmaceutical industry, unforeseen events or changing priorities are not uncommon. How do you handle such situations and maintain your productivity?
Answer: Flexibility and adaptability are key attributes in managing unexpected events or shifting priorities. When faced with such situations, I prioritize tasks based on their urgency and impact on business goals. I believe effective communication with team members is crucial during these times. By keeping everyone informed about changes and adjusting timelines or resources accordingly, we can navigate through challenges seamlessly. Additionally, I focus on innovative problem-solving to identify potential solutions quickly and work collaboratively with the team to address any arising issues. My ability to balance multiple priorities while remaining attentive to details helps me stay productive and deliver results even in dynamic situations.
4. As a Lead Associate, you may need to collaborate with various departments and stakeholders. How do you ensure effective communication and collaboration across teams?
Answer: Effective communication and collaboration are vital in regulatory affairs, as it involves working closely with cross-functional teams. To ensure seamless collaboration, I make an effort to establish open channels of communication with team members and stakeholders. I actively listen to their perspectives, concerns, and suggestions, fostering a collaborative environment where everyone’s input is valued. Regular meetings, both in person and virtually, allow for transparent updates and discussions on ongoing projects. Additionally, I believe in clearly defining roles and responsibilities to avoid any misunderstandings and promote efficient teamwork. By encouraging open communication and valuing diverse perspectives, I ensure successful collaboration across teams.
5. Can you provide an example of a challenging regulatory issue you encountered in your previous role and how you resolved it?
Answer: Certainly! In my previous role, we were preparing for the submission of an Annual Report to a health authority, and during the final review, we discovered a discrepancy in some critical data points. The submission deadline was approaching, and the accuracy of this data was crucial for compliance. To address this challenge, I immediately convened a meeting with the relevant stakeholders from different departments, including manufacturing and quality assurance. We worked collaboratively to investigate the root cause of the discrepancy and conducted an internal audit to verify the data.
By communicating effectively with key stakeholders and prioritizing this issue, we were able to rectify the data discrepancies within the tight timeline. The updated information was successfully incorporated into the Annual Report submission, ensuring its accuracy and compliance with regulatory requirements. This experience taught me the importance of proactive communication and problem-solving in regulatory affairs, as well as the value of collaborative efforts in resolving challenging issues promptly.