Jagdish Bidada

About Jagdish Bidada

A BRIEF SYNOPSIS:A dynamic professional with more than one decade of valuable experience in the areas of Regulatory Affairs (CMC, Administrative, Safety/Labelling & Regulatory operation) with increasing responsibility of portfolio & people management.Implementation of various regulatory strategic initiatives and business process improvements enhancing core business processes resulting in cycle time reduction & enhanced compliance.Project and Client Management for Reg CMC/Operation activities: 1 yrsEffective transition and post-transition implementation of identified CMC activities from outsourcing partners. Oversight of hyper care and BAU state of the activities.Global labelling: 3 yearsUpdates and co-ordination of Global Product Information (PI), International PI, Country Labelling Differences, RTQ Labelling Questions, EU PI (including translations).Global Regulatory CMC and Regulatory operation: 8 YearsDevelopment (Pharma & Biologics):IND/IMPD/Amendments; Briefing Book (BB); Original MAA/NDA; RTQ request; Line extension; Variation applications; Compliance initiatives; LEAN approach; Process improvements; Managing/ Mentoring; Selection/InterviewGenerics molecules: MAA (CP/DCP/MRP); Variation applications; Renewal submission; Compliance initiatives.Formulation and Development: 0.5 years.Oral solid dosage forms (Tables, Capsules and Oral suspensions)Skilled in software application tools: HARMONY, Veeva Vault, Documentum system, eCTDXpress, Docubridge, ISI Publisher, ISI toolbox and validation tools such as Lorenz validator, Extedo.SPOC and SME for XEVMPD activities & eCTD submissions.Certifications:Drug Design & Regulatory Affairs; General course on Intellectual Property; Basics of Project Management; Diploma in Marketing Management.Appreciation award:GOLD Award 2021 – High performer throughout 2020 and consistently demonstrated V&E, Great Mentorship; Excellent project managerSILVER Award 2020– Management of several Complex EU linguistic reviews and SME for Regulatory Veeva Vault for LR process.BRONZE Award 2020– Project Management of EU Work-sharing submission and appreciation for training session/knowledge share session.BRONZE award 2019 - Process/Project Harmonization - For reviewing and migrating the GEP Pack Component Templates into documented system.Appreciation Award 2014– for High Priority and timely eCTD Submission - Karine Corcelle (Submission Manager at Novartis Pharma AG)UGC Scholarship Award - All India Council of Technical Education (AICTE),New Delhi 20••••10University Silver Medal – B. Pharm Degree

Experience

1. Manager, Global Regulatory Lead (Oncology Therapeutic Lead)

   GSK

   Jul 2024 — Present

   Expert in developing and implementing high-impact regulatory strategies for clinical trials, Agency interactions, new registration submissions and post-approval compliance across global regions. Provides strategic guidance and robust regulatory leadership at both project and organizational levels Led approvals of EU CTR, Regional CTAs, substantial modifications and safety submissions Established rapport with EU national authorities and/or CROs, presenting scientific data to strengthen the company’s position Contributed to product strategies, adhered to regulatory processes for assets in all stages of drug development Steered initial registrations and indication extensions with local affiliate Partnered with cross-functional matrix teams to increase regulatory success and study enrolment. Contributed to risk mitigation by identifying regulatory challenges early and collaborating with local and global stakeholders to resolve potential issues.

Education

• GOVERNMENT COLLEGE OF PHARMACY,KARAD

  M.PHARM, BIOPHARMACEUTICS

  2008 — 2010

• Project Management Institute

  PMP, Project Management

• Channbasweshwar Pharmacy College, Latur

  Diploma in Pharmacy, Pharmaceutical Sciences

  2003 — 2005

• D.S.T.S. Mandal's College of Pharmacy

  B.Pharmacy, Pharmaceutical Sciences

  2005 — 2008

Skills

• Life Sciences
• Dissolution
• Formulation
• Generic Programming
• Technology Transfer
• Pharmaceutical Industry
• Sop
• Fda
• Ectd
• Anda
• U.s. Food and Drug Administration (Fda)
• Pharmaceutical Research
• Validation
• Clinical Trials
• Pharmacovigilance
• Gmp
• Regulatory Submissions
• Electronic Common Technical Document (Ectd)
• Regulatory Requirements
• Glp
• Drug Development
• Gcp
• Pharmaceutics
• Drug Discovery
• Regulatory Affairs
• Lifesciences