Vivek Mamidwar - Regulatory Affairs Manager

Q: Where is Vivek based?

Vivek is based in Slough, United Kingdom .

Q: What languages does Vivek speak?

Vivek speaks the following languages: Hindi (Native), Marathi (Native), English (Advanced), German (Intermediate) .

Q: How many years of experience does Vivek have?

Vivek has at least 20 years of experience. During this time, Vivek has worked in at least 7 different roles and for 10 different companies . The average length of individual experience is 2 years . Note that Vivek may not have shared all experience and actually has more experience.

Q: What is Vivek's latest experience?

Vivek's most recent position is Regulatory Affairs Manager at MEL UK Ltd/Trident .

Q: What companies has Vivek worked for in recent years?

In recent years, Vivek has worked for MEL UK Ltd/Trident , AstraZeneca UK Ltd , GSK , and PAREXEL International .

Q: Which industries is Vivek most experienced in?

Vivek is most experienced in industries like Pharmaceutical and Biotechnology .

Q: Which business areas is Vivek most experienced in?

Vivek is most experienced in business areas like Quality Assurance , Product Development , and Project Management . Vivek also has some experience in Research and Development , Legal , and Supply Chain Management .

Q: Which industries has Vivek worked in recently?

Vivek has recently worked in industries like Pharmaceutical and Biotechnology .

Q: Which business areas has Vivek worked in recently?

Vivek has recently worked in business areas like Quality Assurance , Product Development , and Project Management .

Recommended expert

Slough, United Kingdom

Experience

Jun 2025 - Present

10 months

Regulatory Affairs Manager

MEL UK Ltd/Trident

Led and supported management of global CMC regulatory submission processes for biologics, ensuring clinical and commercial documentation enabled Health Authority approvals and investigational product lot release
Coordinated and led pre-submission CMC documentation reviews to ensure alignment with global regulatory requirements and country-specific expectations prior to submission
Provided regulatory oversight for Clinical Trial Applications (Phase I–III), including preparation and maintenance of IMPDs, handling Requests for Technical Queries (RTQs), and ensuring submission readiness
Acted as submission compliance liaison between Global Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply & Logistics, Quality, Pharmaceutical Development, and Manufacturing to ensure accurate and complete documentation supporting product release
Participated in cross-functional governance meetings to identify CMC regulatory risks associated with submission documentation and implemented mitigation strategies to support global development timelines
Drove regulatory strategy by critically evaluating complex submission documents (IMPDs, MAAs, scientific advice packages, quality defect investigations, and Notified Body Opinions) to accelerate clinical development, optimise approval pathways, and support global market access
Led high-level engagement with international regulatory authorities, coordinating cross-functional teams to prepare regulatory meeting packages, manage responses to information requests, and support inspection readiness
Prepared, reviewed, and authored quality documentation (CTD Modules 2 & 3), including process validation, analytical validation, and stability data to ensure compliance with ICH and Health Authority expectations
Led preparation of responses to CMC-related Health Authority questions, contributing scientific and regulatory justifications to support approvals
Provided CMC regulatory submission oversight for CDMOs and CRO partners, ensuring high-quality, compliant, and timely deliverables aligned with global standards
Developed and enhanced regulatory procedures, submission tracking tools, and reporting systems within Veeva Vault RIM to improve submission visibility, compliance, and operational efficiency
Delivered structured submission status updates, regulatory risk assessments, and strategic reporting to senior management and key stakeholders
Implemented process improvements, compliance metrics, and documentation governance frameworks to strengthen submission readiness and audit preparedness
Mentored and guided team members and business users on regulatory submission best practices, RIM system usage, and documentation standards
Led and supported Veeva RIM implementation and migration initiatives, translating regulatory requirements into system configurations and optimized workflows

Nov 2021 - May 2025

3 years 7 months

Regulatory Affairs Manager

AstraZeneca UK Ltd

Led and contributed to global CMC regulatory strategies for biologics, supporting Marketing Authorization Applications (MAAs), Lifecycle Management (LCM), post-approval variations, and renewals across EU, UK, US, and international markets
Prepared, reviewed, and authored quality sections (Modules 2 & 3 of CTD) for new biologics submissions and post-approval changes
Assessed change control and coordinated with Pharmaceutical Development, Manufacturing, QA, and CDMOs/CROs to prepare responses to CMC questions from Health Authorities
Provided regulatory input on procedural and documentation requirements defined by Health Authorities
Prepared and maintained Clinical Trial Applications (CTAs Phase I–III), including IMPD updates and handling RTQs
Executed regulatory filings for CMC changes and variations, including administrative, qualitative, quantitative, safety-related updates, and post-approval commitments
Reviewed source data reports including process validation, stability studies, and analytical method validation
Collaborated with local affiliates, distributors, and agents to clarify submission requirements
Drove regulatory strategy by evaluating complex submission documents to accelerate clinical development and support global market access
Led engagement with international regulatory authorities, preparing regulatory meeting packages and responses
Coordinated third parties (CDMOs/CROs) for MAA submissions
Supported market expansion activities for vaccines and biologics in Wave 2 and Wave 3 markets
Performed change control assessments and regulatory impact evaluations
Authored and prepared labeling documents for export markets
Contributed to multi-disciplinary project teams, identifying regulatory risks and proposing mitigation strategies
Implemented planning, tracking, and archiving of regulatory activities using Veeva Vault RIM
Supported gap analyses and regulatory compliance assessments
Configured and maintained Veeva RIM modules, and led implementation and migration projects
Acted as liaison between business users, Regulatory Affairs, and IT to translate regulatory requirements into technical solutions
Mapped regulatory workflows, identified gaps, and proposed process improvements

Jul 2021 - Oct 2021

4 months

United Kingdom

Senior Regulatory Executive

GSK

Prepared global regulatory strategies including ROW requirements and researched regulatory intelligence for market-specific needs
Authored biologics CMC technical documents for IMPD/IMPD amendments and CTA preparations
Prepared US FDA briefing packages
Authored CMC sections for a humanised, affinity-matured mAb (IgG1) through IMPDs for multiple countries for Phase III
Responded to regulatory agency questions (RTQs)
Prepared detailed CMC documents for EMA and ROW using varied information sources
Liaised with other personnel to ensure document accuracy and captured ongoing project changes
Maintained project status records and highlighted potential delays
Authored, reviewed, and approved registration records in DER Veeva Vault database

Mar 2016 - Jul 2021

5 years 5 months

United Kingdom

Regulatory Consultant

PAREXEL International

Provided regulatory strategic input for development and maintenance of large molecule products
Planned and executed regulatory submissions for EU MAAs (CP, MRP, DCP, NP) and emerging market MAAs (APAC, Europe, MEA, LATAM)
Managed life cycle maintenance activities (worksharing, IA/IB, Type II, grouping, annual reports, renewals)
Authored CMC for decentralised, centralised, and national procedures; reviewed CTD Modules 1–3, ACTD, and international registration files
Developed global regulatory strategies and researched regulatory intelligence
Managed manufacturing site transfers and international CMC variations
Prepared EU post-marketing applications (Type IA, IB, II) for mutual recognition
Authored CMC sections for vaccines including meningococcal group A, C, W-135, and Y conjugate vaccine
Prepared US FDA briefing packages
Acted as subject matter expert for worldwide marketing licensing and maintenance
Assessed change controls and coordinated with CMOs and cross-functional teams
Provided CMC writing, review, and regulatory intelligence consultancy for generics in APAC, Europe, MEA, LATAM
Managed supply chain for generic oncology products
Implemented planning, tracking, and archiving of regulatory activities using Veeva Vault RIM

Jun 2015 - Feb 2016

9 months

Freiburg im Breisgau, Germany

Regulatory Consultant

PAREXEL International GmbH

Provided regulatory services for worldwide marketing licensing and maintenance of pharmaceutical products
Offered CMC writing and regulatory intelligence consultancy for generic products in APAC, Europe, MEA, LATAM
Managed supply chain for generic oncology products

Jul 2012 - May 2015

2 years 11 months

Austria

Regulatory Affairs Manager

Sandoz Biopharmaceuticals and Oncology Injectables (EBEWE Pharma Ges.m.b.H. Nfg.KG)

Prepared dossiers (Module 2/3 and support for Module 1) and managed molecule maintenance for marketed products
Authored variations for minor and major changes in EU and ROW
Submitted renewals on time and responded to Health Authority questions
Maintained internal databases and performed change assessments
Authored US submissions (AR, CBE’s, PAS) for global products
Acted as project manager for internal projects and maintained databases (Trackwise, SAP, SAGE, COI, eCTD Manager)

Aug 2010 - Jun 2012

1 year 11 months

Senior Executive – Regulatory Affairs

Makrocare Clinical Research Ltd

Prepared, reviewed, and managed CMC sections of global regulatory submissions (CTD format) for clinical trial applications, marketing approval, and product maintenance
Authored CMC sections (QOS and Module 3) for CTAs, amendments, registration dossiers, annual reports, and post-approval variations and renewals
Prepared CMC responses to regulatory queries and performed gap analysis against guidance
Ensured technical congruency and compliance with CMC regulatory strategies
Verified submission content

Jul 2008 - Jul 2010

2 years 1 month

Hyderabad, India

Regulatory Associate II

Novartis Healthcare Pvt. Ltd.

Prepared dossiers (Module 3 and QOS) and wrote variations for site transfers, analytical changes, and testing monograph updates
Submitted renewals on time and responded to Health Authority questions
Updated regulatory templates for EU submissions and maintained internal databases (DRAGON, CHARDAS, AQWA)
Authored US submissions (AR, CBE’s, PAS) for global products

Jun 2007 - Jul 2008

1 year 2 months

Ahmedabad, India

Research Associate

Astron Research Limited

Prepared CTD format dossiers and registered pharmaceutical products
Submitted dossiers on time and responded to regulatory queries
Reviewed documents required for submission

Mar 2006 - May 2007

1 year 3 months

Mumbai, India

Office Assistant

Sun Pharmaceutical Industries Limited

Prepared technical packages and DMFs per customer requirements and coordinated with manufacturing for submission data
Conducted preliminary document reviews and maintained databases
Sent DMFs to health authorities and tracked delivery status
Prepared letters of access and coordinated sample and document requests
Maintained electronic databases and performed data entry

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Pharmaceutical and Biotechnology.

Pharmaceutical

Biotechnology

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Product Development, Project Management, Research and Development, Legal, and Supply Chain Management.

Quality Assurance

Product Development

Project Management

Research and Development

Legal

Supply Chain Management

Summary

Highly competent regulatory affairs professional with extensive experience in the pharmaceutical industry, specializing in both pre-approval and post-approval segments while working with leading bio/pharmaceutical companies and CRO. In most recent role at AstraZeneca, I acted as a product lead and supported Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs) and Lifecycle Management (LCM) for small/large molecules, overseeing from regulatory submission strategy to approval for global markets.

Expert regulatory affairs professional with 10+ years of experience in Global Regulatory Affairs Department working for Pharmaceutical, Biotech and CROs/Consultancies. Strategic and operational experience working on MAA (CP/DCP/MRP), CTA (Phase I, II, III), INDS, NDA/BLA, MAA and post approval life cycle (LCM) maintenance activities (Variations CP/DCP/MRP/NP), Renewals, Notifications, Compliance and Conformance) Submissions-CMC, Labelling, Safety and administrative for large (Biologics) and small molecules.

Skills

Cmc Author
Regulatory Strategist
Project Leader
Project Management
Regulatory Affairs
Regulatory Requirements
Bla/maa
Ectd Manager
Veeva Vault
Rims
Regulatory Submissions
Cmc
Ctd Module 3
Pqr
Gmp
Scm
Pmo
Audit Support
Pharmaceutics
Hplc
Product Development
Quality Control
Change Control
Pharma Production
Quality System
Quality Assurance
Sop
Stability Testing
Glp
Ich-gcp
Sap
Oracle
Compliance
Capa
Pharmaceutical Industry
Technology Transfer
Analytical Chemistry
Validation
Quality Management
Fda
Anda
Stability Studies
Oos
Ich Guidelines
Aseptic Processing
21 Cfr Part 11
Ipqa
Cgmp Practices
Batch Release
Fda Gmp

Languages

Hindi

Native

Marathi

Native

English

Advanced

German

Intermediate

Education

Mar 2004 - Mar 2006

DRBAMU

Master’s in Industrial Chemistry · Industrial Chemistry · Chhatrapati Sambhajinagar, India

Mar 2000 - Mar 2003

DRBAMU

Graduated in Physics, Chemistry and Computer science · Physics, Chemistry and Computer science · Chhatrapati Sambhajinagar, India

Statistics

Experience

Total positions 10

Experience in Pharmaceutical 20 y

Avg length 1 y 11 m

Longest experience 5 y 4 m

Global Experience

Countries worked in 4 (India, United Kingdom, Germany, Austria)

Primary country India

Expertise

Recent roles Regulatory Affairs Manager, Senior Regulatory Executive, Regulatory Consultant

Main industries Pharmaceutical, Biotechnology

Main business areas Quality Assurance, Product Development, Project Management

Qualifications

Highest degree Doctorate

Profile

Created

March 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Vivek based?

Vivek is based in Slough, United Kingdom.

What languages does Vivek speak?

Vivek speaks the following languages: Hindi (Native), Marathi (Native), English (Advanced), German (Intermediate).

How many years of experience does Vivek have?

Vivek has at least 20 years of experience. During this time, Vivek has worked in at least 7 different roles and for 10 different companies. The average length of individual experience is 2 years. Note that Vivek may not have shared all experience and actually has more experience.

What roles would Vivek be best suited for?

Based on recent experience, Vivek would be well-suited for roles such as: Regulatory Affairs Manager, Senior Regulatory Executive, Regulatory Consultant.

What is Vivek's latest experience?

Vivek's most recent position is Regulatory Affairs Manager at MEL UK Ltd/Trident.

What companies has Vivek worked for in recent years?

In recent years, Vivek has worked for MEL UK Ltd/Trident, AstraZeneca UK Ltd, GSK, and PAREXEL International.

Which industries is Vivek most experienced in?

Vivek is most experienced in industries like Pharmaceutical and Biotechnology.

Which business areas is Vivek most experienced in?

Vivek is most experienced in business areas like Quality Assurance, Product Development, and Project Management. Vivek also has some experience in Research and Development, Legal, and Supply Chain Management.

Which industries has Vivek worked in recently?

Vivek has recently worked in industries like Pharmaceutical and Biotechnology.

Which business areas has Vivek worked in recently?

Vivek has recently worked in business areas like Quality Assurance, Product Development, and Project Management.

What is Vivek's education?

Vivek holds a Doctorate in Physics, Chemistry and Computer science from DRBAMU and a Master in Industrial Chemistry from DRBAMU.

What is the availability of Vivek?

Vivek is immediately available for suitable projects.

What is the rate of Vivek?

Vivek's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.