AKARSHIT KHARE
Regulatory Affairs Consutant
Summary
Regulatory Affairs professional with over 13 years of experience in regulatory strategy, product registration, and life cycle management across regulated markets including USFDA, EMA, TGA, and WHO. Skilled in preparing and managing regulatory submissions for drug-device combination products and oral solid dosage forms. Proven track record of leading end-to-end regulatory filings, ensuring compliance, and facilitating successful product approvals and commercial launches. Adept at aligning regulatory strategies with evolving global requirements and supporting cross-functional teams in bringing high-quality pharmaceutical products to market.
Overview
12
12
years of professional experience
Work History
Regulatory Services Consultant
AstNova Biopharm
09.2024 - 01.1970
- Company Overview: Focus on Regulatory Services
- Managing overall regulatory compliance and product filing
- Directing development of regulatory strategy and writing regulatory documents for US, EU and other International applications.
- Developing post-approval manufacturing change strategies
- Focus on Regulatory Services
Director of Regulatory Affairs
Zhuhai Resproly Pharmaceutical Technology Co., Ltd
Zhuhai, Guangdong
06.2022 - 06.2024
- Company Overview: Pharmaceutical technology company
- Conceptualizing scientific and technical activities in accordance with FDA and EMA guidelines.
- Directing development of regulatory strategy and writing regulatory documents for US, EU and other International applications.
- Directing the development and preparation of Marketing applications in CTD format and submitting applications as eCTD.
- Developing post approval manufacturing change strategies to allow maximum ease of regulatory approval for continual cost reduction and process improvement programs.
- Acting as the Regulatory Representative for companies during FDA meetings. Representing companies at Pre-IND, Pre-ANDA meetings and other regulatory meetings.
- Directing the start-up activities for clinical studies for US, EU and other International programs.
- Experienced with submission of regulatory dossiers to support clinical trial applications to US, EU and other international agencies (e.g. Australia, Canada).
- Pharmaceutical technology company
- Outstanding Contribution Award: Recognized with the Outstanding Contribution Award at Zhuhai Resproly, reflecting my commitment to enhancing regulatory standards.
- ISCO Award: Awarded by ISCO team to seamless regulatory support on Merck business.
Senior Manager-Regulatory Affairs
Anobri (Anovent) Pharmaceutical Company Ltd
Shanghai & Guangzhou, Guangdong
06.2019 - 05.2022
- Company Overview: Pharmaceutical company focused on combination products
- Responsible for writing Module 2 and Module 3 for DDCs products submissions
- Responsible to prepare Module 1 (administrative part) as per regional requirements for FDA and EMA (including eAF).
- Responsible for life cycle management for Combination Products (Drug-Device combination) to USFDA, EMA and TGA.
- Prepare and submit marketing authorization application (MAA) for European market via National, MRP and DCP route.
- Prepare and submit Controlled Correspondence (Q1/Q2, Device evaluation, Inactive Ingredients and alternative BE approach).
- Responsible to prepare Pre-ANDA meeting package and communicate with FDA agency.
- Providing Trainings to Internal team and cross functional team on current regulatory topics.
- Responsible for preparation of draft labeling, Package Leaflet, SmPC for FDA & EMA.
- Pharmaceutical company focused on combination products
- Provided trainings to internal teams on current regulatory topics.
Expert II, Global Regulatory
Merck Group
Mumbai Area
05.2017 - 06.2019
- Company Overview: Global healthcare company that delivers innovative solutions
- Managed preparation of pharmaceutical CMC modules for submissions
- Handled post-approval variation projects and regulatory compliance activities
- Development of Strategies for regulatory approval for introducing the new products to market/ maintain existing licenses in market, regulatory business planning and forecasting.
- Interface and coordinate with regulatory agencies/competent authorities with respect to submissions, obtaining registrations/licenses/approvals, amendments, regulatory compliance, packaging, quality control testing or release, or other issues.
- Coordinate with global colleagues from US, EU and APAC countries to get the required data for submission purpose.
- Coordination with various Business Groups of Merck or International colleagues for regulatory strategies and all documentation support required for regulatory submissions.
- Post Approval Change management and continuously ensure regulatory compliance. Also ensure and assist Quality function in continuous implementation of the Quality Management System.
- Participate in cross functional team activities from initial stages to securing government approvals and product launches as per business requirements.
- Understand, interpret existing and/or new laws / regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel in a timely manner and implementation of the same to ensure compliance.
- Providing trainings to Internal team and our customers on specific regulatory topics.
- Supporting the business divisions in achieving their target.
- Global healthcare company that delivers innovative solutions
Regulatory Affairs Associate
Mylan
04.2014 - 04.2017
- Company Overview: Global generic and specialty pharmaceuticals company
- Responsible for review and preparation of CMC module for regulatory submissions
- Handling Post Approval Variation projects; PAS, CBE-30, CBE-0, Annual report for US and Type IA, Type IB and Type II EMA.
- Handled Compilation & Review of Annual Reports
- Involved in regulatory queries and responses
- Reviewing regulatory documents (Specifications, Stability Protocols, Batch manufacturing records, Packaging documents, Stability data etc.) required to be submitted to the Health Agencies in support of the new product submission / variations and response to queries.
- Involved in TrackWise Change Control assessment and monitoring regulatory action plan affected by the changes and finalizing the variation strategy.
- Maintenance of tracking sheet for ANDA submissions, amendments, License and their approvals.
- Providing regulatory inputs to various departments (such as QA, QC, R&D, Production) on aspects that would affect their proposed variations.
- To keep the group updated with the latest regulatory guidelines for USFDA Health Agency.
- Global generic and specialty pharmaceuticals company
QA/RA Associate
Ipca Laboratories Limited
02.2012 - 04.2014
- Company Overview: Pharmaceutical company engaged in the manufacturing and marketing of medicines
- Reviewed regulatory documents for new product submissions
- Ensured compliance with cGMP in manufacturing and packaging
- Reviewed and approved SOPs and BMRs
- Pharmaceutical company engaged in the manufacturing and marketing of medicines
Education
Master's Degree - undefined
IPS ACADEMY
02.2012
Bachelor's Degree - undefined
Dr. A.P.J. Abdul Kalam Technical University
05.2010
Accomplishments
- Outstanding Contribution Award, Recognized with the Outstanding Contribution Award at Zhuhai Resproly, reflecting my commitment to enhancing regulatory standards
- ISCO Award, Awarded by ISCO team to seamless regulatory support on Merck business.
Languages
Hindi
English
Marathi
Chinese
Personal Information
- Title: Regulatory Affairs Professional
- Nationality: India
Timeline
Regulatory Services Consultant
AstNova Biopharm
09.2024 - 01.1970
Director of Regulatory Affairs
Zhuhai Resproly Pharmaceutical Technology Co., Ltd
06.2022 - 06.2024
Senior Manager-Regulatory Affairs
Anobri (Anovent) Pharmaceutical Company Ltd
06.2019 - 05.2022
Expert II, Global Regulatory
Merck Group
05.2017 - 06.2019
Regulatory Affairs Associate
Mylan
04.2014 - 04.2017
QA/RA Associate
Ipca Laboratories Limited
02.2012 - 04.2014
Master's Degree - undefined
IPS ACADEMY
Bachelor's Degree - undefined
Dr. A.P.J. Abdul Kalam Technical University
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