SWAPNIL DHAGE

I am a results-driven pharmaceutical regulatory affairs professional with over 11 years of experience leading teams through regulatory submissions and compliance. I effectively translate complex regulatory requirements into actionable strategies and promote collaboration among interdisciplinary teams to achieve product approvals on time. My expertise includes Initial Dossier Filings (CMC), Life Cycle Management, and Risk Management, supported by a proactive,problem-solving approach. With strong attention to detail and a strategic mindset, I ensure that innovation aligns with regulatory standards.

• Glenmark Business Excellence Award for filling out and getting approval for the EU MAA within the target timeline, and for process improvement.
• Genpact global Cheers award in COURAGEOUS and INCISIVE categories for “excellent contribution in initial project set-up and training for Vaccine US Annual Report CMC new joiners.

• GPAT/BPT/NIPER (04/2011 - 04/2012) (04/2011 - 04/2012), MS Baroda, ICT Mumbai, and NIPER, two times GPAT qualified from M.S.U., Baroda, in 2011 and 2012, and bagged the UGC fellowship from 2012 to 2014
  Qualified NIPER JEE 2011 and BPT exam 2012 for M. Tech. (ICT, Mumbai).

• IT Skillset: MS office, Publishing tools-eCTD software's, Track-wise (for CC) and Documentum, MEDIVA, Share Points, Power BI Tools, eDMS, Liquent InSight, PRISM, Citrix, sHEDS, SPECTRUM, HARMONY, GRACE, RIMS, TRS Viewer

• Team management experience with knowledge in pre-formulation and formulation development, including initial filings for solid, semi-solid, liquid, dermal, parental, critical ophthalmic, and peptide injectable dosage forms.
• Oversees CMC strategy and submissions for a product portfolio at various development stages. Collaborates with regulatory agencies to shape global policy and identify risks while creating mitigation plans. Mentors junior staff, defines regulatory strategies, and manages submission requirements. Develop response strategies for health authority inquiries and coordinate with development and commercial teams to align timelines. Works with local teams on filing strategies and maintains submission tracking systems, ensuring adherence to regulatory processes for cross-product alignment.
• Experience in authoring and reviewing complete CMC dossier sections for MAA, IND, IMPD, and NDA submissions.
• Deficiencies in response management for the EU market for initial and post-approval activities.
• Preparation of renewal MA Transfers, Switching of RMS, Article 61(3) packages.
• Experience in post-approval changes (variations), deficiency responses, and reviews for – type IA, type IB, group IB, and type II through RUP/DCP/National for the EU Market and the US and Global market for small molecules, vaccines, and biologicals.
• Worked on CP, DCP, Nationals, MRP, Piggyback (informed consent), change of ownership, and duplicate applications for Europe.
• Aware of publishing software such as eCTD Express and PharmaReady, and submission gateways including CESP, MHRA, AIFA, and the Portugal portals (Inframed).
• Providing regulatory and quality inputs, I support scientific and technical due diligence as needed, offering expert advice on marketing authorization (MA) and manufacturing compliance. I assist various international customers by delivering key strategic inputs, such as approving the Pre-EB Checklist, Product Development Report (PDR), Heat Testing (HT), Stability Studies, In-Use Protocols, Performance Verification Report (PVR), HT Review, and any other projects requiring technical support. Additionally, I am involved in regulatory project management activities.

• 1. Formulation and Evaluation of sustained release Microspheres of Atorvastatin using Chitosan and Alginate, Int. J. Pharm. Sci. Drug Res. 2017; 9(3): 126-133, S. G. Dhage, G. K. Lohiya, Y. M. Charde*, J. G. Avari, DOI:10.25004/IJPSDR.2017.090305.

• EDQM Certification on Impurity Control in the Ph.Eur.,Reference Standard, Fundamentals of CEP Procedure.Year-July-2021

• Received 'Corona Yoddha' certification in the year 2021 from MSPC, India
• Active Blood Donner