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5.0 - 10.0 years

7 - 14 Lacs

Hyderabad

Work from Office

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Role & responsibilities: Prepare, review, and compile ANDA submissions in eCTD format, ensuring high-quality, complete, and compliant dossiers with minimum supervision. Review and finalize Module 1, 2, and 3 documents, including CMC sections, in coordination with R&D, QC, and QA. Draft and update product labeling (PI, carton, container, SPL) in accordance with FDA requirements and internal templates. Support pre- and post-submission activities, including preparation of amendments, annual reports, controlled correspondences, and supplements (CBE-0, CBE-30, PAS). Collaborate with cross-functional teams to gather required documentation and data to meet submission timelines. Participate in the preparation of responses to FDA deficiencies/CRLs, ensuring scientific justification and regulatory compliance. Maintain up-to-date knowledge of US FDA regulations, guidance documents, and industry trends affecting sterile and complex generics. Maintain submission tracking systems and regulatory archives for assigned products. Preferred candidate profile: 5 - 10 years of relevant experience in US Regulatory Affairs with a focus on sterile dosage forms (injectables, peptides, microspheres, BFS, nasal sprays, ophthalmics, ointments). Strong working knowledge of ANDA submission structure, eCTD publishing tools, and regulatory systems. Hands-on experience in drafting or reviewing CMC documentation (Module 3) and labeling components. Experience in working with multidisciplinary teams to manage submission deliverables. Familiarity with FDA communications, controlled correspondences, and post-approval reporting requirements. Excellent organizational, documentation, and communication skills. Interested candidates can share your updated cv to talent@difgen.com

Posted 1 day ago

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9.0 - 14.0 years

0 - 1 Lacs

Pune

Work from Office

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ASSISTANT ACCOUNT MANAGER Job Title - Assistant Account Manager, only from R2R, GL background. Location: Pune (India) Reports to- Account Manager Shift: Primarily Evening shift or Flexible. Experience: 10 to 12 years Job Type: Full-time The Assistant Account Manager will support the Account Manager in client management, financial analysis, and reporting while ensuring operational excellence, team development, and process adherence. This role requires a strong background in Record-to-Report (R2R) and General Ledger (GL). A key responsibility is managing work assignments, balancing team workload based on individual capacity and skill levels, and optimizing productivity. The AAM will drive the team to meet deadlines and provide high-quality client deliverables, while effectively managing resources and fostering skill development. Key Responsibilities: Client Management: Serve as a reliable and consistent point of contact for client inquiries, handling all communications (email, calls, Slack, etc.) effectively and proactively addressing queries to support the Account Manager. Prepare for client meetings, including organizing agendas, taking meeting minutes, and summarizing client meetings with action items and next steps. Strong written and verbal English communication skills, including clarity in written tone, making emails simple and easy to read. Independently manage selected clients, ensuring timely and accurate delivery of services. Support strong client satisfaction through accurate and timely work delivery. Be prepared to field any client-related questions, proactively resolving issues to free up the Account Manager's time. Know Your Customer: Research clients thoroughly by exploring their financials or websites - understanding their vision, mission and core values and identifying their key priorities and pain points. Ensure this understanding is incorporated into client interactions and deliverables, aligning services with their goals to provide tailored and impactful solutions. Ensure that you are proactively anticipating client needs based on their business focus and play a key role in enhancing satisfaction and trust. Financial Analysis and Reporting: Conduct detailed financial analysis and review financial statements for clients, identifying trends or issues. Execute the month end close process, ensuring accurate and timely completion of reconciliations, journal entries, and financial reporting. Develop financial plans, forecasts, and budgets for clients in collaboration with the Account Manager. Ensure compliance with accounting standards, such as GAAP, and help clients stay updated on relevant regulations. Manage and support the 1099 tax process and other tax-related services. Audit Support: Coordinate audit activities, including preparing schedules, gathering documentation, and liaising with auditors to ensure a smooth audit process. Perform a final review of all audit schedules and financial support documents prior to client or auditor review. Team Management and Development: Monitor the time tracking of team members working on managed client engagements, checking their time logs at regular intervals throughout the day to ensure accuracy and proper allocation. Ensure client work is completed within the budgeted time. Conduct comprehensive workload analysis and planning, assigning deadlines for all tasks delegated within the team to provide ample review time prior to client due dates. Guide and mentor junior staff, providing training and helping them develop skills in accounting and client management. Foster team development by giving feedback on communication skills, transparency, ownership, effort, quality, and mindset during performance reviews and as needed. Identify high-potential team members and create development plans to prepare them for advanced responsibilities. Encourage cross-training among team members to ensure versatility and reduce dependency on specific individuals as well as create flexibility within the team to share workload effectively. Provide clear expectations and constructive feedback to team members on an ongoing basis. This may occur immediately after client interactions, during regular one-on-one meetings, or as situations warrant. Document outcomes of these feedback sessions. Operational Excellence: Conduct research to resolve internal queries. Proactively update the Account Manager on project status. Encourage team members to identify and come up with process improvements ideas and support in implementing the best practices for improvement in quality, customer satisfaction or efficiency of the process. Maintain process documentation to reflect changes and improve team effectiveness. Take ownership of personal and team performance, ensuring accountability and results. Process Standardization: Work with the team to identify opportunities to standardize processes and workflows, ensuring consistency and efficiency across all client engagements. Supporting Team Documentation Make sure the team follows all required processes, including: Completing month-end trackers Using Canopy for project management Maintaining Service Improvement Tracker, Client Relationship Tracker Keeping client-specific documents up-to-date Attention to Management initiatives such as OKRs Check and approve step-by-step guides (SOPs) for all client work. Use existing how-to guides and resources to help the team work better. Look for ways to improve how we do accounting for clients, focusing on making things faster and more accurate. Collaboration and Teamwork: Foster collaboration and teamwork within and across teams (e.g., tax specialists, auditors). Work closely with the Account Manager to ensure seamless service delivery to clients. Promote a positive and motivated work environment where every team member is valued. Foster Sutro Li company values such as transparency, collaboration, generosity, and self-discipline. Qualifications Minimum Bachelor's degree in accounting or related field, MBA or CA inter preferred Proficient in Microsoft Excel and other accounting software. The successful candidate will have a strong background in GL accounting and experience working with US GAAP. AP background not required. Thorough understanding of nonprofit accounting principles added advantage. Ability to apply accounting principles and solutions to meet unique client needs and clearly articulate proposed solutions to client's problems. Ready to work in evening shift (5:30PM to 2:30AM IST) or any other shift that business requires. Willingness to work from office or home or in hybrid model as per the requirements. Self-starter, work with minimum guidance, ability and willingness to go extra mile to meet business requirements

Posted 1 week ago

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