Saurabh Dudhewar
Almere Stad
Summary
Accomplished regulatory affairs professional with extensive experience in developing and executing regulatory strategies for pharmaceutical products. Proven track record of securing approvals and ensuring compliance across diverse markets. A collaborative leader adept at cross-functional communication and driving successful product launches.
Overview
22
22
years of professional experience
Work History
Associate Director/Global RA Lead Biosimilar Business Unit
Biogen B.V
11.2021 - Current
- Developing and delivering innovative global regulatory strategies for product development, approval, and LCM activities for assigned assets in alignment with thglobal business strategy
- Developing and executing the Global Regulatory Plan and strategy across major territories and accounting for the requirements of their Health Authorities (including EU, US and JP)
- Development of master briefing documents for multi-regional scientific advice
- Leading the regulatory activities for the development, registration, and Life-Cycle
- Managing of Biosimilar asset(s), across multiple indications and/or development stages and for ensuring compliance
- Representing the company with domestic and international regulatory authorities, contractors, and corporate partners
- Managing of outsourcing and vendor management for in-country RA execution, medical/regulatory writing
- Providing regulatory support for cross product activities/workstreams, input into regulatory policy, and across various projects teams, functions, partners, and committees
- Steering and supporting regulatory team members and/or direct reports
- Key Accomplishments: Successfully delivered on-time submission of the biosimilar MAA, BLA applications
- Successfully prepared/represented company for major health authority interactions
- Global trainer on different types of agency advice meetings
- SME life cycle management
- Serving as an RA/QA
- Mentoring, training, coaching, developing new team members.
Registration Manager
Sandoz B.V
01.2013 - 10.2021
- Directly co-ordinate all project activities for the registration of generic medicinal products, both on a national and EU-wide scale for all therapeutic areas
- Ensure the timely completion and submission of applications for MRP, DCP, CP, and line extensions
- Manage post-approval dossier maintenance functions through quality and safety variations
- Interpret regulatory guidelines, conduct gap analysis, author product information, and conduct CMC document review
- Complete risk assessments and manage deviations
- Support complex divestment projects
- Maintain extensive knowledge of generic industry, regulatory guidelines, EMA scientific advice, PIP applications, IA/IB/II variations, new regulatory MAA application strategies, MAH transfers and MAH withdrawal
- Company contact point for EU health authorities
- Provide life cycle management and MAA application training to new RA managers and associates
- Provide RA support for regulatory activities associated with partnering activities, including due diligence for in- and out-licensing activities
- Key Accomplishments: Successfully delivered on-time submission of variations, national applications, and CPs, DCPs for key projects in EU region (including CH nationals)
- Successful launch of generic/innovative medicines in EU
- Recognized as a subject matter expert with respect to submission of quality safety variations and new applications for OTC, application within EU
- Completed professional exchange program with CMC (Chemistry, Manufacturing & Control) department in India
- Saved time and costs in complex MAA and divestment projects
- Served as a Sandoz global trainer and a member of the Sandoz Global Training Academy
- SME Initial MAA and lifecycle management for NovaRIM and SARA.
Quality Assurance Supervisor
Merck India Ltd
09.2008 - 09.2009
- Led in-process quality assurance (IPQA) function for injectable production activities, ensuring compliance with GMP guidelines
- Conducted BMR (batch manufacturing record) and BRP (batch packing record) review
- Initiated and monitored process simulation study within the aseptic filling area
- Performed in-process sampling of products for validation
- Managed line clearance activities for manufacturing and packing operations
- Key Accomplishments: Achieved zero quality issues in batches post-line clearance
- Diligently managed in-process control, audit preparation, and media fill management activities
- Effectively maintained the internal quality management system (QMS).
Production Executive
Merck India Ltd
01.2002 - 05.2006
- Provided team leadership while coordinating all production activities for injectable formulations
- Delivered training and coaching to new staff members
- Managed preparation, review, maintenance, and updates of SOP in line with cGMP guidelines
- Completed in-depth analysis and assessment of production issues; reported on overall equipment effectiveness (OEE)
- Produced and delivered annual product quality reports
- Managed audit preparation activities
- Key Accomplishments: Ensured the continuous operation of production and packing lines in a cost-effective manner
- Directly managed and trained team members to maintain full compliance with relevant standards and regulations.
Education
Msc Drug Discovery and safety -
Vrije University
Amsterdam, Netherlands09.2012
Bachelor of pharmacy - Pharmacy
Amravati University
Pusad09.2006
Skills
- Early/late stage product development
- Regulatory strategy
- EU regulatory requirements, MAA application/LCM activities expert
- Health authority interaction
- Dossier/labeling preparation
- Risk assessment & mitigations
- Project management
- Leadership/Cross-functional collaboration
- Mentoring/Training
- SAP; Production and Planning Module
Honours Awards
- Being Accountable for publishing handover of a project
- Being Recognized for customer focused for FDA/EMA interaction
Certificates Courses
- Global Strategic planning in RA (TOPRA)
- Coaching skills for Leaders and Managers (Linkedin Learning)
- Business communication in RA (Sandoz Finance NL)
- What are clinical trials (Cornerstone)
- Current RAPS Member
- Communication fundamentals (Linkedin Learning)
Projects
NovaRIM (Novartis Regulatory Information Management) and SARA (Sandoz Regulatory Affairs document management) SME (Subject Matter Expert) Initial MAA & lifecycle management representing Sandoz providing feedback based on the Sandoz needs, Performing testing and data migration scripts.
Lean Six Sigma GB Project: Increasing the organization master data accuracy
Languages
English
Native language
Dutch
Intermediate
B1
German
Beginner
A1
Timeline
Associate Director/Global RA Lead Biosimilar Business Unit
Biogen B.V
11.2021 - Current
Registration Manager
Sandoz B.V
01.2013 - 10.2021
Quality Assurance Supervisor
Merck India Ltd
09.2008 - 09.2009
Production Executive
Merck India Ltd
01.2002 - 05.2006
Msc Drug Discovery and safety -
Vrije University
Bachelor of pharmacy - Pharmacy
Amravati University
Similar Profiles
Twinkle S. ChowdhuryTwinkle S. Chowdhury
Principal Associate Scientist at Biogen Inc.Principal Associate Scientist at Biogen Inc.
Paula BoonePaula Boone
Senior Supervisor, PF QA Shop Floor at BiogenSenior Supervisor, PF QA Shop Floor at Biogen
Tiffany ColacchioTiffany Colacchio
Principal Analyst, Data Stewardship at Biogen IdecPrincipal Analyst, Data Stewardship at Biogen Idec