Regulatory Affairs CMC

Rajan Thumar, MS

*** * ******** **, ******, MA **171 512-***-**** *************@*****.***

SUMMARY

As an experienced regulatory affairs CMC professional, I am a strategic leader, thinker, and problem solver with expertise in large and small molecules. With 10+ years of regulatory experience, extensive knowledge of global biopharma regulations and guidance documents, I have a strong track record of successfully navigating products through clinical development, marketing application approval, and commercialization. SKILLS

● Strong knowledge of GCP, GMP, ICH and Health

Authority guidances

● Quality by Design (QbD)

● Veeva Vault, Trackwise, Liquent InSight, GPRS,

RAPIDdirect, Adobe Suite

● 21 CFR 314.420(G) - DMF

● eCTD structure

● Project management & Risk assessment

● Strong attention to details & Team management

● Solution driven and passion for simplification

EXPERIENCE

Syner-G BioPharma Consulting LLC Framingham, MA

● Associate Director, Regulatory Affairs CMC Jan 2022 – May 2023

Led CMC-related regulatory activities for early and late-stage clinical products, including small molecules and biologics such as mAb’s, ADC’s, and NDA’s.

Authored the quality content of Module 3 (CMC) for regulatory submissions in support of biologics and small molecules at various stages of development, such as IND, CTA/IMPD, NDA, and MAA

Spearheaded the planning, preparation, and authoring of meeting request documents and briefing books for health authority interactions, including Type B, Type C, and Scientific Advice.

Developed a risk register and contingency plans for CMC-based risks associated with pharmaceutical development and regulatory compliance.

Managed a team of 2 regulatory professionals responsible for post-approval CMC submissions.

● Sr. Manager, Regulatory Affairs CMC Jan 2021 – Dec 2021

Led the planning, preparation, and submission of high-quality global CMC-related applications, including IND/CTA/IMPD submissions and responses to regulatory agency inquiries for KEYTRUDA.

Developed and implemented regulatory strategies for CMC post-approval supplements in the US, EU, Japan, and ROW countries, covering various types of submissions such as PAS, CBE-30, CBE-0, Type II, Type 1B, Type 1A, Partial Change Application, Level 1, Level 2, and Level 3.

Provided impact assessments for change controls related to manufacturing processes, analytical methods, and product quality.

Collaborated with cross-functional teams during the authoring and review of regulatory submissions to ensure compliance, scientific excellence, accuracy, and completeness.

Initiated a lunch-and-learn program and collaborated with SMEs for regulatory hot topics.

● Manager, Regulatory Affairs CMC Sep 2019 – Dec 2020

Assisted in the authoring of Module 3 CMC content (3.2.S and 3.2.P) for NDA submissions, using source documents such as analytical methods description, method validation, specifications, JOS, batch analyses, & stability data.

Created and managed a comprehensive regulatory database to track and analyze health authority responses and trends for specific topics, improving efficiency and compliance at Syner-G.

● Consultant II, Regulatory Affairs CMC Jan 2018 – Aug 2019

Assisted in authoring post-approval submissions for marketed products, including CBE-30, CBE-0, Annual Report, Type 1B, and Type 1A.

Collaborated with cross-functional CMC teams to attain 100% timely submission that includes authoring, reviewing, and approving CMC content.

Developed CMC content for post-approval submissions and amendments in emerging markets.

● Jr. Consultant, Regulatory Affairs Feb 2016 – Dec 2017

Assisted in reviewing and approving CMC content for US Annual reports across various programs.

Conducted impact assessments for quality changes in change control processes related to annual reports.

Contributed to the planning, preparation, and review of CMC content plans for quality changes in marketed products.

RiconPharma LLC Denville, NJ

Sr. Associate, Regulatory Affairs May 2015 – Feb 2016

● Prepare CMC components of IND, briefing package, annual reports etc.

● Develop and review sterility assurance package for injectable products

● Provided regulatory assessments for manufacturing changes and prepare respective submissions

● Compile and review quality agreements and vendor qualification for CMO’s and vendors Syner-G BioPharma Consulting LLC Framingham, MA

Internship, Regulatory Affairs Mar 2014 – May 2014

● Authored and reviewed Module 2 and Module 3 documents for regulatory submissions.

● Assessed change controls and prepared post-approval submissions. Reliance Formulations India

Associate, Regulatory Affairs May 2012 – Dec 2012

● Established and reviewed specifications, analytical methods, and validation protocols for drug substance and drug product.

● Reviewed and approved master batch records for drug product manufacturing and filling. Gujarat PharmaLab Pvt. Ltd India

Manufacturing Compliance Specialist Jun 2011 – May 2012

● Prepared and reviewed method validation protocols, manufacturing batch records (MBR), cleaning validations, and qualification reports.

● Assisted in the preparation of standard operating procedures (SOPs) for equipment and products used in manufacturing.

● Coordinated with the team in the preparation of cGMP annual audit. EDUCATION

Massachusetts College of Pharmacy and Health Sciences (MCPHS University) Boston, MA Master of Science in Regulatory Affairs and Health Policy, May 2015 Pune University Pune, India

Pharmacy, May 2011

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