Manish Sharma

• Team handling.
• Effective handling of the product registration for Mexico, Malaysia, and Thailand.
• Handling of variation filing.
• Planning for dossier filing.
• Managing the completion of the project as per the assigned timeline.

Handling ROW: Asia, ASEAN, LAC, and NAC.

• Improved dossier submission with minimum queries.
• Handling queries effectively to obtain product registration.
• Coordinating with customers and internal departments.
• Accomplishing multiple tasks within established timeframes.
• Managing and motivating team members to be productive and engaged in their work.
• Led a team of six employees, ensuring high productivity and excellent customer service.

• ROW Markets- Latam, African, ASEAN, CIS, GCC
• Successfully participated in tenders for Kenya, Mauritania, Burundi, Madagascar.
• Increase client satisfaction for dossier quality for getting fast registrations.
• Coordination with clients- tracking dossier status, query status, reply to their queries.
• Query Handling- Responding to queries raised by clients and FDA.
• Handling COPPs & Product Permissions.
• Review of dossiers before submission.
• Team Handling- Work assigning, Problem solving, Support for dossier preparation.
• Coordination with plant- Follows-up for document requirements.
• Tracking for samples- Generating sample requirements for registration purpose and taking follow-ups.
• Maintaining country wise all products status.
• Maintaining status of all over work of team and updating to manager.
• Established objectives to offer team members clear roadmap to help company achieve overall goals.
• Helped with planning schedules and delegating assignments to meet pharmaceutical product registration.

• Planning for new products as per requirements of parties. (Recently worked for 20 fresh new products)
• Coordination with QA, QC, Production and R&D department for respective documents of Pharmaceutical formulations.
• Review artwork according to export registration requirements, arranging samples for registration purpose
• Review of technical documents received from QA, QC, Production and R&D department.
• Review of dossiers as per requirements.
• Queries handling from respective health authorities.
• Product status update & regulatory report to Manager Drug Regulatory Affairs regarding dossiers.

• Prepare of dossier for registration of pharmaceutical products like Tablet, Capsules, Liquids and dry Injection within required time frame as per CTD, ACTD and regional format for various countries.
• Regions handled: AFRICAN, ASEAN, CIS, LATAM.
• Review of technical documents received from QA, QC, Production and R&D department.
• Dosage form handled: Solid, Liquid and dry Injectable formulations as per requirements.
• To evaluate & respond to queries arise from respective health authorities.
• To conduct reference study search in libraries/ internet for accumulating comparative technical data of various formulations.

• Supporting Corporate DRA for preparation of dossiers.
• Coordination with different departments within plant.
• Review of all CMC documents.
• Handling queries received from corporate DRA and getting them solved with help of respective department in plant.

• Shadowed senior team members to learn all related jobs and tasks.
• Attended training courses to build understanding of processes, techniques and industry.
• Participated in on-job training, working closely with supervisors and coworkers and asking appropriate questions.
• Preparation of dossiers under guidance of supervisors and coworkers.
• Supported organizational objectives with help from existing employees.
• Supported departmental tasks to increase understanding of industry processes.
• Maintained punctuality in work attendance and project completion.