Mukesh Rathod
Specialist Regulatory Affairs
Bangalore
Summary
Highly skilled Regulatory Affairs Specialist with extensive experience in preparing and reviewing eCTD, CTD, and country-specific dossiers. Demonstrated expertise in managing and coordinating the preparation of regulatory documents to facilitate regulatory submission activities, such as post-approval variations, Renewals, and Responses to objections in ROW and EU markets. Proficient in creating and updating application, event, regulatory objective, registration, and submission content plans in Veeva Vault for ROW and EU markets.
Overview
9
9
years of professional experience
3
3
Language
6
6
Certifications
6
6
Skills
Work History
Specialist Regulatory Affairs
MERCK KGaA
Bangalore
07.2021 - Current
- Total 2 Years of work experience at Merck, accountable for managing and coordinating preparation of regulatory documentation for regulatory submissions
- Proven ability to maintain product licenses, execute strategies, and streamline operations in alignment with headquarters functions
- Responsible for creating RTQ (query response) packages and post-approval CMC variations
- I have meticulously planned and successfully executed around 122 product submissions to health authority
- These submissions include range of activities such as renewals, Initial Marketing Authorization (MA), responses to inquiries, and post-approval variations
- Proficient in creating and updating application, event, regulatory objective, registration, and submission content plans in Veeva Vault RIMS for ROW and EU markets
- Experience in updating promotional materials in VERITAS Promo material application and handling product submissions for Portugal
- Skilled in supporting Module 1 preparation, providing certificates and statements, and assisting in authoring as needed
- Support GRL/CRA or other stakeholders in executing regulatory strategies and project managing regulatory submissions for medicinal products in partnership with GRA’s external strategic partner while working closely with Global Regulatory Marketed Products Operations Management group
- Excellent track record in tracking submission roll-outs, maintaining dossier lists, and ensuring regulatory compliance for global dossier submissions.
Lead Associate
Genpact Pvt. Ltd.
Mumbai
10.2018 - 07.2021
- Total Work experience in Genpact: approx. 3 years and Working cross-functional for ROW Market
- Plan and prioritize project activities to produce high-quality deliverables on time
- Strategy development, status update, Pre-screening, authoring and delivery of project
- Responsible for preparation of post-approval variation and RTQ (query response) packages
- Tracking, tracing and archiving of various registration documents through global systems like RCAM (First Doc), RSDM (Veeva Vault), Orion (Liquent Insight), COGNOS, Red Compass, Submission planning tool (TCS) and Trackwise
- Responsible for authoring of quality documents by using ISI writer tool
- Responsible for creation of project plan by using Submission planning tool
- Resolved problems, improved operations, and provided exceptional client support.
Regulatory Affairs Officer
IPCA Laboratories Ltd.
Mumbai
03.2016 - 09.2018
- Total Work experience in Ipca Lab: 2.8 years, and worked for Middle East and Latin America markets.
- Responsible for New registrations, renewals, filing variations/post approval changes, and query response to Middle East and Latin America markets.
- E-CTD dossier prepared for Middle Eastern countries
- Prepared FDA documents (COPP and FSC) for Legalization.
- Artwork checked and Approved as per country requirements
- Coordination with the country manager, Export department, R&D department, Manufacturing location and other internal departments for regulatory activities.
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
Executive Regulatory Affairs
Aztec Pharma (P) LTD
Mumbai
02.2015 - 02.2016
- Total Work experience in Aztec Pharma: 1.2 years; worked for ROW Market
- Compilation and Filing of dossiers for Medical devices for Ethiopia, Sri Lanka, and Ghana.
- Prepared of FDA documents and Power of attorney for Legalization
- Art work checked as per MOH requirement
- Participated in export tender work for timely submission
- Arrange and dispatch all documents and samples related to registration purposes.
Education
Master of Pharmacy - Pharmaceutics
R.C. Patel College Of Pharmacy
Shirpur, Dhule 06.2013 - 11.2015
Bachelor of Pharmacy - Pharmacy
NGSPM's College Of Pharmacy
Nashik 06.2008 - 04.2013
HSC -
Yashwant Junior College
Ahmedpur, Latur Board 03.2005 - 02.2006
SSC -
Bahirji Smarak Vidyalaya
Basmath, Aurangabad Board 06.2002 - 03.2003
Skills
Veeva Vault RIM
undefinedCertification
Veeva Vault (RIMS)
Timeline
Specialist Regulatory Affairs
MERCK KGaA
07.2021 - Current
Lead Associate
Genpact Pvt. Ltd.
10.2018 - 07.2021
Regulatory Affairs Officer
IPCA Laboratories Ltd.
03.2016 - 09.2018
Executive Regulatory Affairs
Aztec Pharma (P) LTD
02.2015 - 02.2016
Master of Pharmacy - Pharmaceutics
R.C. Patel College Of Pharmacy
06.2013 - 11.2015
Bachelor of Pharmacy - Pharmacy
NGSPM's College Of Pharmacy
06.2008 - 04.2013
HSC -
Yashwant Junior College
03.2005 - 02.2006
SSC -
Bahirji Smarak Vidyalaya
06.2002 - 03.2003
References
- Paritosh Chaukiyal, Syneos Health, Mob. 9137975145
- Gunvant Shirsath, Genpact, Mumbai, Mob. 9082125956
- Adesh Bhor, TCS, Mumbai, Mob. 8779383726
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