Mitul Tilala

• Developing and executing comprehensive CMC strategies for all assigned projects as per regulatory requirements and company goals. • Collaborating with cross-functional teams to prepare and compile CMC documents for INDs, IMPDs and CTAs. • Authoring, reviewing and maintaining life-cycle management of CMC documents in Veeva system. • Providing technical oversight and guidance to internal and external stakeholders regarding CMC processes, manufacturing, analytical development, and quality control. • Identifying potential risks and challenges related to CMC activities, proactively developing mitigation strategies, and coordinating and collaborating with stake holders for decision making processes. • Collaborating closely with R&D, Manufacturing, Quality Assurance, Regulatory Affairs, and other teams to ensure seamless integration of CMC activities into overall project timelines and objectives. • Ensuring compliance with cGMP and other relevant industry regulations, standards, and guidelines to maintain the highest quality of the drug products.

• Executed regulatory strategies by leading the development, authoring, and review of NDAs CMC submission component and documentation to support post-approval supplements and responses to health authority questions per established business processes and systems. • Provided input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks. • Submitted more than 80 global submissions including post-approval variations, OMA, and baseline submissions for the global market (CENCA, APAC, LATAM, EU, EMEA, US). • Independently managing projects per client correspondence by coordinating, communicating with diverse teams, reviewing, authoring, and compiling the submission package for global variation filing. • Coordinating with HQ, iCMC, CRA, and various teams to identify the supply impact or complexity of the project for prioritizing the projects and supporting cross-functional teams to achieve their target timelines. • Accessed and communicated potential regulatory risk and proposed mitigation strategies. • Delivered all regulatory milestones for assigned products across the product life cycle. • Product/Project analysis, and maintenance of trackers to meet the assigned timelines. • Managed and trained direct reports for assigned projects and ensured their quality of work and timeliness on deliverables. • Supported clients by performing their submission reviews in a timely manner. • Dedicated Second Person Review for HQ and Genpact US team. • Conducted and led the online presentation to the client on the importance and process of Dedicated Second Person Review for process improvement and ultimately to improve the quality of submission. • Hands on experience with the client’s internal systems such as, Veevavault RSDM, RADR, Reliant, Orion, Cognos, SPT, Trackwise, Liquent Insight, ETQ, etc. • Received a Star Silver award from Organon for Q1-2022 for best performance in my job.

• Managed regulatory strategic filings with CMOs from around the world (India, Taiwan, Germany, etc.) • Prepared Original ANDA submissions. • Prepared and submitted the Annual Report for ANDAs and NDAs. • Prepared and submitted responses to deficiencies (CR, IR, ECD) for pending ANDA applications. • Prepared and submitted various post approval supplements (PAS, CBE-30 and CBE-0 Supplements). • Reviewed and approved change controls using QUMAS and Process Compliance. • Reviewed and Approved Regulatory Assessment done by junior associates on change controls. • Represented Regulatory Affairs during product development meetings and site transfers project meetings. • Maintained the portfolio that included Oral Solid, Topical, Parenteral, Ophthalmic and Otic dosage forms of the formulation. • Guided and trained junior regulatory affairs associates. • Developed and maintained the FTP server and Media-Shuttle for sharing regulatory documents between Alvogen and CMOs.

• Prepared and submitted Annual Reports to maintain Product Life Cycle. • Prepared and submitted Quarterly and Annual Periodic Adverse Drugs Experience Report (Paper and Electronic). • Prepared and submitted Controlled Correspondence to the Agency. • Compiled and Published (using MedXview, EDUCE) Dossier in eCTD format and submitted to FDA through Electronic Submissions Gateway (ESG). • Managed regulatory-related activities with vendors. • Assisted in preparation and submission of Original ANDAs, Amendments, and Supplements, in an eCTD format for Modules 1, 2, 3 and 5. • Coordinated with various departments and ensured the timelines are met. • Maintained records and tracking for FDA correspondence activities. • Reviewed and approved Change Controls, Labels, IPAS, Trade Dress proposal documents. • Reviewed strategic filing of Original ANDAs.

• Split-redacted and complied required documents mapped it to eCTD format. • Tracked monthly and ongoing project errors for IQC. • IQC’ed the formatting of collation analyst builds. • Knowledge of Regulatory submissions like IND, NDA, ANDA, CTA, 510(k), PMA, and annual report. • Familiar with FDA regulation, eCTD, ICH guidelines, variation, renewal, knowledge of IND/NDA.

• Conducted primary and secondary market research to support the development of new business for the company’s broad range of OTC products. Delivered presentations to customers on products. Collaborated with all other departments within the company to implement marketing strategies.

• Graded assignments and conducted recitations for Pharm.D. students enrolled in various courses, including Public Health, Behavior & Ethics, and Communication.

• Researched whether phone calls or text messaging can improve well-being in patients with Type 2 diabetes. Collected primary data for the project from the 2009 Diabetes-Expo Conference.

• Managed production batches, while maintaining stringent GMP regulations. Established and maintained customer relationships.

• Gained in-house experience in the manufacture and GMP regulatory filing documentation of pharmaceutical dosage forms such as tablets, capsules, oral liquids, and ointments.