Regulatory Affairs Project Manager

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ABHISHEK HARDE

RAC, PMP

********.*****@*****.*** 857-***-**** linkedin.com/in/abhishekharde Massachusetts, USA PROFESSIONAL SUMMARY

Detail-oriented, Regulatory Affairs certified (RAC) and PMP professional with overall 15 years of multi- disciplinary experience in Life Sciences, including more than 5 years dedicated to Regulatory Affairs and Operations functions. I am passionate about contributing to bring novel and/or better treatment to patients using my scientific, business and technical expertise. Core Competencies include: Cross-functional Team Collaboration Communication Problem Solving Adaptability Project Management. Business Process Improvement Critical Thinking Regulatory Strategy Drug Development Submissions Due Diligence KEY ACHIEVEMENTS

• Developed multi-level, integrated business process maps for planning, executing and tracking regulatory activities in the Product Registration and Submission Management system by collaborating with Clinical Development, Non-clinical, CMC, Labeling, Pharmacovigilance, Compliance and partners.

• Adept at maintaining compliance and delivering results supporting multi-faceted projects in Business Analyst and Project Manager roles.

PROFESSIONAL EXPERIENCE

ICON Plc Cambridge, MA

Sr. Manager, Regulatory Affairs Feb 2020 – Present Providing Regulatory strategy consulting and operational support to Takeda in a complex environment. Regulatory Strategy, RIM and Submissions:

• Supported Regulatory lead in planning, executing and tracking regulatory strategies for product registration.

• Streamlined global regulatory processes for minor and major filings including INDs, BLAs, and MAAs.

• Managed process for Health Authority correspondences, including questions, commitments and outcomes.

• Contributed to future state regulatory data and process maintenance operating model for global and local teams to improve efficiency.

Regulatory Compliance:

• Co-led workstream to manage updates to regulatory affairs SOPs ensuring compliance.

• Aligned lifecycle maintenance and safety reports submissions requirements adhering agency regulations. Cross-Functional Collaboration:

• Collaborated with teams including Clinical Development, Nonclinical Development, Quality Assurance, CMC, Labeling and Compliance to formulate integrated process.

• Collaborated with the CMC Submission, Publishing to track Certificates of pharmaceutical products, import authorization, ancillary documents, legalization to fulfill agency requirements. EY Life Sciences Iselin, NJ

Advisory Senior Mar 2016 – Jan 2020

Part of the Quality and Regulatory Compliance competency in the Risk Transformation - Life Sciences practice.

• Served as Project Manager in areas of Quality, Computer System Validation and Regulatory Compliance.

• Evaluated the overall drug development process to improve business performance.

• Performed FDA mock audit to comply with GxP regulations such as CFR part 210, 211, 11, 820 and MHRA.

• Addressed challenges in Complaints Management, CAPA Management, and GxP Compliance processes and systems.

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ABHISHEK HARDE MBA, PMP, RAC

• Monitored progress, managed risk, and kept key stakeholders informed about progress and expected outcomes for successful project delivery.

• Mentored and trained staff in implementing GxP predicate rules and regulatory guidelines. Cognizant Technology Solutions Life Sciences USA and India Business Analyst Sep 2008 – Mar 2013

Delivered global consulting projects to enhance clinical development and improving operational performance. Clinical Operations

• Defined and implemented clinical operations metrics ensuring clinical trials are compliant with the FDA and EMA requirements.

• Developed business capability presentations and sales pitch documents contributing pre-sales.

• Conducted competitor benchmarking analysis for clinical operations product suites. Consultant Mar 2013 – Mar 2016

Drive global consulting projects to augment Regulatory Operations, improving business performance. Regulatory Operations

• Consulted global regulatory, local affiliates and division leads for planning registration management system.

• Accountable for managing schedule, deliverables, priorities, progress updates for two workstreams.

• Defined, elicited, and documented RIM project requirements collaborating with multiple teams. EDUCATION

Master of Business Administration (MBA) • In Progress USA Isenberg School of Management, UMass Amherst Nov 2021 – Present MBA in Pharmaceutical Management India

National Institute of Pharmaceutical Education and Research (NIPER) Jul 2006 – Jul 2008 Awarded Merit-based Scholarship for excellence.

Bachelor of Pharmacy (B.Pharm.) India

Ganpat University – Shree S.K.Patel College of Pharmaceutical Education and Research Apr 2002 – May 2006 CERTIFICATIONS AND AFFIALITIONS

Project Management Professional (PMP) • Issued since Nov 2019 Affiliated with Project Management Institute (PMI) Regulatory Affairs Certification (RAC) - US • Issued since Jul 2014 Affiliated with Regulatory Affairs Professionals Society (RAPS) Machine Learning: From Data to Decisions completed in Nov 2019 Certificate course offered by MIT

TRAINING, CONFERENCES AND TOOLS

• Accomplished Strategic Planning in Project Management training course offered by PMI.

• Participated in various Regulatory Submission Strategy and Project Management courses offered by RAPS.

• Participated in workshops hosted by FDA and EMA to keep abreast of current regulations.

• Tools: Veeva Vault RIM, Liquent Insight, Publishing (Docubridge), Microsoft Office, Project, PowerBI. RESEARCH AND PUBLICATIONS

• Research: Harde A. (2007). Design Product Development Strategy to fulfil various regulatory requirements for marketing authorization of drugs in the US and EU.

• Publication: Harde A., Takes P., Nozawa S. (2020). Setting up a Quality Management System: Global Medical Device Regulatory Strategy published by RAPS, Second Edition, p59-92.

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