Summary
Work History
Education
Skills
Certification
Timeline
Generic
DARSHAN VYAS

DARSHAN VYAS

MANAGER
Mumbai

Summary

Regulatory Affairs professional with 5+ years of experience in Global CMC Regulatory Affairs, regulatory strategy, CTD/eCTD submissions, Module 3 authoring and review, dossier compilation, and lifecycle management across Rest of the World (RoW) markets. Experienced in regulatory submissions and registrations for biologics, biosimilars, NCEs, generics, OTC products, and small molecules. Independently managed 50+ regulatory submissions and post-approval change applications, contributed to 100+ global submissions, and supported registrations across 30+ countries, working with 30+ products and 20+ pharmaceutical clients. Proficient in Veeva Vault RIM, eCTDmanager, eValidator, SAP, SharePoint, Microsoft Project, and AI-powered regulatory intelligence tools. Strong in regulatory compliance, cross-functional collaboration, risk mitigation, and team mentoring.

Work History

Assistant Manager - QA

Freyr Solutions
04.2026 - Current
  • Lead CMC regulatory affairs activities for registrations, variations, renewals, and lifecycle management across RoW markets.
  • Developed regulatory strategies that facilitated product approvals, and ensured compliance in emerging markets.
  • Manage regulatory activities for small molecules, OTC products, generics, biologics, and biosimilars across RoW markets.
  • Collaborated with Quality, Manufacturing, Supply Chain, and client stakeholders to align on, and achieve regulatory objectives.
  • Support high-quality, compliant CTD Module 3 dossiers, cross-functional alignment, and efficient global submissions.
  • Managed regulatory activities for small molecules, OTC products, generics, biologics, and biosimilars, enhancing compliance across RoW markets.
  • Use Veeva Vault RIM, eCTDmanager, and eValidator for submission planning and compliance.
  • Mentor team members, and support continuous process improvement initiatives.
  • Key achievements reported in the source profile include 50+ independent submissions and post-approval change applications, and registrations supported across 30+ countries.

CMC Specialist / Team Lead

Freyr Solutions
06.2024 - 04.2026
  • Led dossier preparation, technical review, submission planning, and lifecycle management for global pharmaceutical clients.
  • Ensured high-quality CTD Module 3 dossiers and alignment between technical data and global health authority expectations.
  • Designed and executed regulatory strategies tailored to RoW markets, and evolving regional frameworks.
  • Facilitated client engagements and regulatory strategy discussions to enhance understanding of emerging market requirements.
  • Conducted regulatory intelligence assessments to support market expansion strategies.
  • Collaborated with multidisciplinary teams to deliver high-quality submissions on time.
  • Streamlined submissions and mentored specialists, improving cross-functional alignment and operational excellence.
  • Leveraged expertise in RoW market strategies, biologics and biosimilars, CMC, generics development, and CTD Module 3 authoring to effectively manage health authority queries.

Senior Associate

Freyr Solutions
04.2022 - 05.2024
  • Delivered end-to-end regulatory solutions and consulting support for global pharmaceutical clients.
  • Coordinated submission workflows and maintained product lifecycles to ensure compliance with evolving international guidelines.
  • Prepared and reviewed CTD/eCTD dossiers for new registrations and lifecycle management.
  • Compiled global NDA, MAA, and variation submissions using eCTD software.
  • Supported variations, renewals, change control assessments, and health authority response activities.
  • Compiled and submitted global NDA, MAA, and variation submissions using eCTD software, enhancing regulatory approval processes.
  • Oversaw post-approval variations and lifecycle maintenance for product portfolios across RoW markets, ensuring alignment with regulatory requirements.
  • Maintained on-time delivery of high-priority client regulatory deliverables.
  • Evaluated complex controls for compliance with GMP, and ICH guidelines.

Management Trainee

Freyr Solutions
06.2021 - 03.2022
  • Contributed to regulatory intelligence projects, dossier preparation, and lifecycle management activities to ensure compliance.
  • Assisted in assessing regional regulatory requirements for global markets to inform strategic planning.
  • Completed Freyr’s fast-track management trainee program, focused on CMC strategy and regulatory operations for RoW emerging markets.
  • Assisted with regional regulatory requirement assessments for global markets.
  • Mapped regulatory intelligence for RoW markets, including ASEAN, LATAM, and MENA, enhancing client compliance strategies.
  • Contributed to the technical review and compilation of CMC dossiers, tailored to regional health authority frameworks.
  • Supported regulatory intelligence projects, dossier preparation, and lifecycle management activities.

Education

Master of Business Administration (MBA.) - Pharmaceutical Technology & Healthcare Management, Pharmaceutical Marketing and Management

SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Mumbai, India
01-2021

Master of Pharmacy (M.Pharm.) - Pharmaceutical Technology, Pharmacy, Pharmaceutical Sciences, and Administration

SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Mumbai, India
01-2021

Bachelor of Pharmacy (B.Pharm.) - Pharmaceutical Sciences

Bombay College of Pharmacy
Mumbai, India
01-2018

Skills

Regulatory Affairs & CMC: Regulatory Affairs CMC, Global Regulatory Strategy, Regulatory Intelligence, CMC Documentation Management

Global Registrations & Market Access: Rest of World (RoW) Market Registration, Market Access and Registration Planning, Emerging Market Regulations, Marketing Authorization Applications

Regulatory Submissions & Dossier Management: CTD/eCTD Dossier Compilation, CTD Module 3 Authoring and Review, NDA/MAA Submissions, Variations and Renewals, Post-Approval Change Management, Regulatory Lifecycle Management

Regulatory Compliance & Assessment: Change Control Assessment, Health Authority Query Management and Responses, Regulatory Risk Assessment, Technical Documentation Review, Regulatory Gap Analysis, Good Manufacturing Practice (GMP) Compliance, International Council for Harmonisation (ICH) Guidelines

Product Registration Expertise: Biologics, Biosimilars, New Chemical Entities (NCEs), Generic Drugs, Over-the-Counter (OTC) Products, Small Molecules

Leadership & Stakeholder Management: Department Management, Leadership and Mentorship, Client Engagement, Cross-functional Collaboration, Customer Relationship Management (CRM), Project Management

Certification

Registered Pharmacist

Timeline

Assistant Manager - QA

Freyr Solutions
04.2026 - Current

CMC Specialist / Team Lead

Freyr Solutions
06.2024 - 04.2026

Senior Associate

Freyr Solutions
04.2022 - 05.2024

Management Trainee

Freyr Solutions
06.2021 - 03.2022

Master of Business Administration (MBA.) - Pharmaceutical Technology & Healthcare Management, Pharmaceutical Marketing and Management

SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

Master of Pharmacy (M.Pharm.) - Pharmaceutical Technology, Pharmacy, Pharmaceutical Sciences, and Administration

SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

Bachelor of Pharmacy (B.Pharm.) - Pharmaceutical Sciences

Bombay College of Pharmacy

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