Genpact Recruitment – B Pharma/M Pharma Regulatory Affairs Job
Dont forget to check out possible interview questions for this job below
Genpact hiring a regulatory affairs manager. Manager job opening 2023, Pharma job opening 2023, B Pharma job opening 2023, Pharma job opening 2023, Regulatory affairs job opening 2023. Intrested and eligible candidates may check out all the details
Job Title: Manager – Regulatory Affairs-LIF008713
Primary Location India-Mumbai
Qualifications
Minimum Qualifications
• B. Pham/M.Pharm/Science Graduate
• Experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, Extedo,etc.
• Handled a direct team of publishers
• In-depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
• Effective time management and organizational skills
• Effective communication
• Flexibility to adapt to a changing environment
Preferred Qualifications / Skills
• Pharmacy
Responsibilities
The Role demands for an experienced Submission Manager with demonstrated ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to
• Managing the operations and team
• Taking care of administrative responsibilities of team
• Project & resource management
• Team management and team engagement
• Should be technical expert in eCTD/CTD submissions of US/EU/Canada and Row market
• Hands on experience on submissions
• Capability to trouble shoot technical validation errors
• Good client communication skills
• Flexible attitude
• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for Asia pacific, Europe Submissions and US submissions
• Performing final technical quality review.
• Dispatching submission to the relevant authority (eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;
• Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;
• Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
• Co-ordinate with client/stakeholders
Apply Online
Possible Interview Answers and Questions for the above job:
- What experience do you have in managing a team of publishers and ensuring successful submission of regulatory documents for multiple markets?
Answer: I have managed a team of publishers for several years and have experience in submitting regulatory documents for US/EU/Canada and other regions using eCTD/CTD/NeeS/Paper formats. I have also worked with various publishing tools such as Liquent, Docubridge, and Extedo, and have the capability to troubleshoot technical validation errors.
2. How do you ensure timely delivery of regulatory documents while managing multiple projects and resources?
Answer: I prioritize tasks and allocate resources based on the criticality of each project. I have effective time management and organizational skills that help me ensure timely delivery of regulatory documents. I also maintain effective communication with stakeholders to keep them informed about the progress of the project.
3. Can you describe your experience in dealing with health authorities and capturing submissions-related correspondence?
Answer: I have worked closely with health authorities and have experience in capturing submissions-related correspondence such as uploading documentation, commitments, and metadata. I have also received acknowledgments from authorities for submission receipts and communicated them to key stakeholders.
4. How do you ensure effective team engagement and communication while managing a team?
Answer: I ensure effective team engagement by delegating responsibilities and encouraging team members to take ownership of their work. I also maintain open communication channels and encourage team members to provide feedback and suggestions. I conduct regular team meetings and one-on-one sessions to discuss project progress and address any issues or concerns.
5. How do you stay updated with the latest regulatory guidelines and submission requirements?
Answer: I stay updated with the latest regulatory guidelines and submission requirements by attending conferences, training sessions, and workshops. I also keep myself updated by reading relevant literature and publications, and networking with regulatory professionals. I ensure that my team is also aware of the latest developments in the regulatory landscape.
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