Ram Mohan Kathuroju Email & Phone Number

Congers, New York, Us

• Leading the regulatory function for regulatory submissions of IND, NDAs, ANDAs, Amendments and Supplements.• Successfully managed/prepared CMC document packages in support of initial submissions of INDs and Type B & C meeting packages.• Negotiations with FDA as a point of regulatory contact and getting approvals timely.• Liaison with API vendors, reviewing type II DMFs and effectively resolving issues with DMF CRLs related to Chartwell’s NDA/ANDAs.• Liaison with legal/regulatory/patent attorneys.• Due diligence review/audits of NDAs/ANDAs for potential acquisitions

• Led the Regulatory Affairs Department, by mentoring and empowering the team to function independently with the least supervision and high-quality output.• Developed the filing strategies, collaborated with cross-functional teams and reviewed, compiled and submitted more than 75 high-quality original ANDA applications for solid oral (IR/MR tablets, capsules, soft gels, powders), and liquid oral, including complex generics, several amendment submissions in response to inquiries from FDA, and several post approval supplements and annual reports.• Liaised with internal and external counsel as a point of contact, for more than ten patent litigations, testified in three Rule 30(b)(6) depositions at the capacity of corporate designee.• Ensured the compliance with regulatory guidances and company regulatory goals and timelines, by participating, directing the cross-functional team during development meetings and guiding on the content, format of submissions.• Ensured faster approvals of post approval changes in compliance with SUPAC guidances, by effectively reviewing, approving change controls and deciding on the appropriate reporting category.• Ensured faster approvals of applications, getting state/DEA licenses, release of imported APIs by effectively acting as liaison between company and State Department of Health, Bureau of Narcotics, DEA, FDA at port of entries, OGD/OPQ RBPMs/RPMs/Division Directors and participated in several regulatory inspections, and conference calls.• Effectively managed the life cycle of approved applications by meeting the post approval reporting requirements.• Effectively complied the post approval drug safety reporting requirement by supervising, guiding the Pharmacovigilance and drug safety functions. Successfully faced FDA PV inspections with zero observations.

• Reported to the Chairman/MD.• Successfully led the regulatory affairs and regulatory compliance functions of Belcher Pharmaceuticals, LLC, Largo, FL as well as American Antibiotics Inc, Baltimore, MD (a sister company) for generic human, veterinary and β-Lactam Antibiotics applications such as ANDAs / ANADAs (vet)/ amendments, supplements, and annual reports.

• Successfully established the regulatory team, mentored, guided on the regulatory submissions and compliance functions.• Successfully led the submission / received approvals of Para IV ANDAs, semi-synthetic antibiotics and PIND package for a 505(b)(2) application, several Post Approval Site transfer supplements, Amendments and Annual reports. Submitted and received approval for ANADA (Abbreviated New Animal Drug Application), and JINAD (Generic Investigational New Animal Drug) filings from CVM, FDA.• Successfully handled several FDA pre-/post-approval inspections, DEA and Department of Health, Florida inspections as a point of contact. Established the systems, supervised and reporting done for controlled substances. • Effectively contributed to critical review and approval of all CMC documents in the facilities.• Designed, reviewed, and approved product Labels/Labeling, and carve outs.• WebTrader account setup, SPL submissions, Establishment Registration, Labeler Code, and Drug Listings.• Liaised with OGD, CVM, FDA Dist. offices, business partners, legal counsels, and consultants as point of contact.• Ensured compliance with the cGMPs, post approval requirements by guiding and reviewing/approving Change controls, deviations, OOS or Batch failure investigations/CAPA.• Effectively handled 3 product recalls by coordinating with FDA recall coordinator and product distributors.• Handled Medwatch for human drugs / Adverse events reporting of Vet drugs.• Handled a medical device 510(k) filing and life cycle management by liaising with CDRH.

• Reported to Joint Director, Drug Regulatory Affairs.• Successfully led the team of 10 Regulatory Associates, guided preparation of ANDAs and MAAs for Oncological Injectables (liquids/lyophilized powders in ampoules or vials) in eCTD.• Played a key role as part of the ‘new Generics team’ by imparting training on the CFRs, ANDA guidances, conducting internal audits, writing eCTD templates and QbR for parenteral ANDAs.• Supervised and practically involved in the preparation of generic human Oncological Injectable applications such as ANDAs and MAAs.• Designed the CTD template and QbR for parenteral ANDAs.• Wrote 5 ANDAs for US FDA and 5 MAAs for UK MHRA.• Provided remote regulatory CMC support to the manufacturing site in UK.• Prepared Sterility Assurance Validation Packages for ANDAs for products manufacturing by Aseptic fill process using barrier isolator technology or Terminal Sterilization Injectable, parenteral oncology products. • Prepared and submitted Controlled Correspondences to FDA.• Participated in conference calls with FDA.• Participated in Product Development Team meetings as RA representative and educated the team on FDA/EMEA guidances.• Prepared Technology Transfer Documents to Manufacturing plant in UK.• Involved in selection, evaluation of vendors for eCTD publishing software tools and supervised its installation, qualification and validation. • Supervised, audited and coordinated with contract manufacturing sites for ANDA batch execution, data collection, review and approve.

Hyderabad, Ts, In

• Reported to Director-IRA.• Led a team of five RA associates.• Ensured submissions were planned and prepared with high quality and meeting strict timelines, for ANDAs and UK MAAs, amendments, supplements, variations, and annual reports for solid oral dosage forms (IR/MR tablets and capsules).• Prepared / supervised and submitted ANDAs for US FDA including Para IV filings. • Involved in the preparation of CMC sections of 505(b)(2) applications. • Prepared and submitted MAA for UK MHRA in CTD.• Supervised, reviewed, and mailed documents requested by the company legal counsels in the USA during subpoenas.• Reviewed and approved various CMC documents from Formulation development, Analytical development and Production required for application submissions.• Participated in weekly Product Development meetings as department representative.• Prepared Site Master Files and Quality Manual. Prepared RA SOPs and trained RA executives/officers.• Represented the RA department in ISO standards 9001:2000 certification and ISO standards 14001 certifications.

Hyderabad, Telangana, In

• Led the Drug Regulatory Affairs department.• Reviewed and written CMC sections of four ANDAs for customers on contract development as site RA.• Prepared and filed several dossiers in emerging markets viz: Brazil, Russia, China, South Africa, Latin America, Middle East, and Southeast Asia for small volume parenteral dosage forms in ampoules, vials and pre-filled syringes (PFS).• Dealt with Regulatory/GMP consultants and regulatory personnel of domestic/overseas customers in the process of regulatory submissions.• Reviewed and approved controlled documents including Equipment qualifications, analytical method validations, Batch Manufacturing Records, Specifications, Test Methods, method validations, process validations, Stability for cGMP compliance.• Participated in cleanroom facility qualifications and equipment qualifications such as IQ/OQ/PQs of processing equipment for rubber stopper cleaning & siliconization, Ampoule/vial depyrogenation tunnels, sterilization autoclaves, and media fill validations of filling lines. • Coordinated with R&D in Product Development, specification setting, BMR preparation, validation reports and stability data review. • Functioned as third-party products’ technology transferring expert.• Trained as Lead Auditor from University of Portsmouth, UK and conducted Internal Quality Audits.• Played a key role in ISO standards 9001:1994 certification as Deputy Management Representative.• Handled third party cGMP / quality systems audits.

Other; Hmx Pro Online Certificate Program - Drug Discovery And Development

Other; Hmx Pro Online Certificate Program - Clinical Drug Development

Master Of Pharmacy, Pharmaceutical Biotechnology

Currently Pursuing Ph.D In Pharmaceutical Technology, Pharmaceutical Science