Vrushali Tambe
Senior Director Regulatory Affairs
Mumbai
Summary
Regulatory Affairs expert with 15+ years of experience in CMC regulatory strategy, authoring, and lifecycle management for Biologics and Combination Products. Proven track record of leading global submissions, regulatory impact assessments, and cross-functional collaborations to ensure compliance and optimize approval timelines. Adept at driving operational excellence and regulatory efficiencies.
Overview
18
18
years of professional experience
10058
10058
years of post-secondary education
Work History
Senior Director - Regulatory Affairs
G&L Scientific
09.2018 - Current
- Instrumental in setting up the Mumbai Centre of Excellence and successfully establishing the Regulatory CMC and Publishing Project Teams.
- Providing leadership and strategic direction to Regulatory teams supporting global CMC and Publishing teams of major Pharma & Biotech companies.
- Effectively interpreting global CMC regulations & guidelines and providing regulatory advice to the clients and stakeholders through drug product lifecycle.
- Collaborating with clients for planning, authoring, and submission of high-quality CMC submissions for new applications and post-approval changes according to defined timelines.
- Leading design and implementation of regulatory processes to optimize submission timelines.
- Maintaining strong working relationships, directing multi-functional teams, planning, and prioritizing multiple short and long-term projects.
- Driving the in-house Technical Training Program for the Regulatory Teams.
- Leading and contributing to development and implementation of global & regional plans and policies.
- Strengthening team capabilities by identifying and mentoring talent for evolving project needs.
- Actively contributing to global collaboration initiatives, enhancing team exposure and cross-functional learning.
Senior Manager - Regulatory Affairs, Post-approval CMC, Biologics
Genpact India (former Pharmalink Consulting)
09.2012 - 08.2018
- Designed regulatory strategies and implementation plans for the preparation and submission of new marketing applications and PLCM activities.
- Assessed quality changes for regulatory impact on regulatory strategy and product status.
- Planned, authored, reviewed, and submitted regulatory submissions in accordance with established regional regulations, product supply and other critical timelines.
- Developed strategic partnerships with internal and external clients, which contributed to the acquisition/renewal of engagements for longer terms.
- Ensured performance metrics, KPIs and SLAs were met and delivered in accordance with time, cost, and quality expectations.
- Monitored regulatory submission plans, communicated progress to Senior Management and mitigated any risks from emerging technical data or external threats.
- Reviewed and interpreted new regulations and ensured that they were communicated through company policies and procedures.
- As a part of Six Sigma Green Belt certification, validated and improved client’s US Annual Reports process including designing of communication tools and trackers, which resulted in reduction of processing time by approx. 20%.
- Supervised several Lean projects initiated by team members which helped drive operational excellence.
Clinical Research Coordinator, Clinical R&D and Medical Affairs – Biologicals
GlaxoSmithKline Pharmaceuticals Ltd.
11.2011 - 09.2012
Executive – Production & Process Development, API Department
Bharat Serums And Vaccines Ltd.
07.2007 - 11.2008
Education
Regulatory Affairs Certification - Drugs
Regulatory Affairs Professionals Society
09.2022
PG Diploma in Operations Management -
Welingkar Institute of Management
06.2013
PG Diploma in Drug Regulatory Affairs -
IPER
06.2009
M.Sc. - Biotechnology
Goa University
06.2007
B.Sc. - Microbiology, Vocational Biotechnology
University of Mumbai (Ruia College)
06.2005
Skills
- Global Submission Strategy & Planning
- CMC Authoring (Module 2 & 3 - Quality)
- Dossier Compilation and review
- Global Regulatory Guidelines
- Regulatory Impact Assessment
- Post-approval Lifecycle Maintenance (PLCM)
- Compliance Gap Analysis & Remediation
- Project Management
- Cross-functional Stakeholders Management
- Designing & Improvising Business Processes
- Client management
- Leadership & Team Building
- Training & Mentoring
- Resourcing
- Multi-cultural Communication
Accomplishments
- 150+ New Marketing Applications Globally
- Brexit Amendments for 900+ protocols over 150+ INDs
- 500+ Major and Minor variations/ supplements across US, EU, Canada, Japan, and Rest of World (RoW)
- 350+ Global License Renewals annually for NDAs, ANDAs & BLAs
- 350+ US FDA Annual Reports for INDs, NDAs, ANDAs and BLAs
- 20+ Canada Yearly Biologic Product Reports (YBPRs), since 2014
Timeline
Senior Director - Regulatory Affairs
G&L Scientific
09.2018 - Current
Senior Manager - Regulatory Affairs, Post-approval CMC, Biologics
Genpact India (former Pharmalink Consulting)
09.2012 - 08.2018
Clinical Research Coordinator, Clinical R&D and Medical Affairs – Biologicals
GlaxoSmithKline Pharmaceuticals Ltd.
11.2011 - 09.2012
Executive – Production & Process Development, API Department
Bharat Serums And Vaccines Ltd.
07.2007 - 11.2008
Regulatory Affairs Certification - Drugs
Regulatory Affairs Professionals Society
PG Diploma in Operations Management -
Welingkar Institute of Management
PG Diploma in Drug Regulatory Affairs -
IPER
M.Sc. - Biotechnology
Goa University
B.Sc. - Microbiology, Vocational Biotechnology
University of Mumbai (Ruia College)
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