Genpact is inviting applications for the role of Lead Associate, Regulatory Affairs – APPLY NOW
Job role : Lead Associate
Company : Genpact
Primary Location : India-Mumbai
Schedule : Full-time
Education Level : Bachelor’s / Graduation / Equivalent
Master Skills List : Operations
Job Category : Full Time
Department : Regulatory Affairs
job ID : LIF012815
- 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
- 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.
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Here are some potential interview questions and answers for the role of Lead Associate in Regulatory Affairs at Genpact:
- Can you provide an overview of your educational background and experience that aligns with the requirements of this role?Answer: Certainly. I hold a Bachelor’s degree in Pharmacy from [Your University], and I have over 4 years of experience in the pharmaceutical industry. My educational background and professional experience have equipped me with a solid understanding of regulatory affairs and the pharmaceutical landscape.
- How familiar are you with annual report submission processes and regulatory requirements?Answer: I’m well-versed in annual report submission processes and regulatory standards. I understand the importance of timely and accurate submissions to health authorities, and I’m experienced in coordinating various submission activities, such as data collection, review, and release.
- Could you elaborate on your experience in handling regulatory document management systems such as ORION, COGNOS, VEEVA, REDS, and SPARS?Answer: Certainly. I have hands-on experience with various regulatory document management systems like ORION, COGNOS, VEEVA, REDS, and SPARS. These platforms play a critical role in organizing, tracking, and managing regulatory documentation, ensuring compliance with internal processes and industry standards.
- How do you ensure accurate and timely responses to health authority questions or subsidiary requests?Answer: Accuracy and timeliness are priorities in responding to health authority queries. I have a proven ability to efficiently gather the required information, collaborate with cross-functional teams, and provide comprehensive responses that address the questions while adhering to regulatory guidelines.
- Can you discuss your experience in preparing Administrative Content (Module 1) for annual reports in the US market?Answer: Certainly. I have hands-on experience in preparing Administrative Content (Module 1) for annual reports targeting the US market. This involves compiling and formatting necessary administrative information and ensuring that it aligns with the specific requirements set forth by regulatory authorities.
- How do you handle coordinating with clients and providing project status updates?Answer: Effective coordination and communication with clients are crucial in project management. I’m skilled at maintaining regular communication, providing updates on project progress, and addressing any concerns or inquiries that clients may have.
ALL THE BEST !