Khushal Gite

• Leading a team of eight people in all aspects of worldwide regulatory post-approval activity.
• Offering strategic support in the development of regulatory submissions and the schedule for assigned projects or products, as well as team assistance when needed.
• Review and verify that the data and documents included in the regulatory submission are accurate and of high quality.
• Contribute to ROW INTS-renewal plans and regulatory submissions.
• Create a plan for submitting those variations after reviewing Change Control evaluations for the US, EU, and CAN worldwide markets.
• Drug substance assessment and DMF change control review to ensure that supplier-driven changes, excipient, and DS are correctly assessed.

Ensuring compliance throughout the life cycle:

• Evaluate and review pre-CMC and supplier-driven change assessments for drug substances and excipient for all regulatory regions. Additionally, let procurement and stakeholders know how the proposed change will affect them.
• Reviewing the post-approval submissions from Canada. such as SANDS and SNDS, and LIII notifications).
• Responsible for timely EU variation submissions (post-approval submissions). (IAIN, IB, Type II, and Type IA). and variations in the USA. (CBE-0, CBE-30, PAS, )
• Examining GCC-MENA applications for CPP, renewals, and post-approval submissions.
• Managed projects and MA Transfer submissions for the ROW, GCC, and MENA regions.
• Monitor the schedules of both planned and completed tasks, and identify any issues impeding the project's advancement.
• Attend and proactively participate in regulatory, cross-functional team meetings which include a leader from different locations and departments.
• Schedules, prioritizes, and assigns projects [i.e., PLCM submissions and deficiency responses. Review of change control record assessment (CCR), supplier-driven changes (SDC) & pre-CMC changes and other department-driven projects etc.] to Regulatory Affairs team members to ensure business timelines are met.
• Supervises the work of direct reports, determining training requirements, performing regular performance reviews, and executing development plans in coordination with the Reporting Manager.
• Regular interactions with stakeholders to discuss on expectations, deliverables/priorities and provide solutions to regulatory issues and/or problems.
• Coaches, progressions, and provides guidance to other team members in the preparation of quality submissions and other functional tasks.
• Maintained positive, professional working environment to optimize staff and customer satisfaction.
• Collaborated with the HR department on recruitment, interviewing, and selecting new team members.
• Led weekly team meetings to discuss targets, performance, and address any issues promptly.
• Liaised with international partners to ensure alignment of regulatory strategies and submissions across markets.
• Managed submission of regulatory documents to health authorities, adhering to strict timelines and guidelines.
• Developed and maintained a comprehensive regulatory affairs database, tracking submission statuses and regulatory commitments.
• Prepared detailed reports on regulatory strategies and submission plans for senior management review.
• Facilitated training sessions for staff on compliance standards, regulations, and best practices.

• CTD Module 2: Quality Overall Summary writing for global markets in eCTD format;
• Modules 1, Preparation and review of Adminitrative documents (LOA, CPP, Cover letters, TOC)
• Modules 3: CMC dossiers for solid oral dosage forms (tablets and capsules) were prepared and reviewed.
• Prepare, review, and submit responses to inquiries from international regulatory bodies.
• Coordination of documents needed for dossier and question response preparations with industry cross-functional teams.
• Type IA, Type IB, and Type II Variation packages for EU PLCM were prepared and ready to be submitted.
• Prepared and reviewed License Renewals Packages for LATAM, Europe Union, and South African markets. CTD Conversion (Reformatting information from old Part II dossier into new CTD format)
• Quality Review for Dossier Collation and Preparation as per HA requirement (For US and EU region).
• Review the BMR, stability study data, comparative dissolution profile data, COA, and test reports.
• Gap analysis between registered documents and plant practices, and preparation of CMC review documents for the same.

• The preparation of applications for state GMP, chemist approval, and COPP.
• Reviewed MFR, BMR, change control, deviation, and other documents are prepared, reviewed, and • Examining the stability data, specifications, and protocol.
• Examining the stability data, specs, and protocol
• Assist the leader in evaluating and qualifying vendors for raw materials. Getting license applications ready to submit to the FDA at the local or state level.
• Paying in-person visits to the CDSCO and State FDA offices to get clarification and resolve different issues.
• To coordinate with FDA officials, DCGI, and statutory agencies, as well as with state-level drug authorities to handle concerns pertaining to quality.

Worked in Formulation-Granulation dept. for the formulation of batches for the Development of ANDA Products for the US Market & Technology Transfer Batches with Optimization, Qualification Batches for New Products along with documentation.
Worked with Production supervisors and completed production target as per GMP norms and production plans ·
Handling Granulation and compression area. Also, individually handling binding of products in granulation.
Active audit team member for various audits like WHO Audit, Local FDA Audit, USFDA AUDIT, and active member of the team of Total Quality Management (TQM) in IPCA Laboratories Ltd.

Facilitated communication between departments, ensuring smooth operations throughout the entire production cycle.