Regulatory Affairs Senior Manager

Vaishnavi Sundararaman, Regulatory Affairs Professional

New Jersey, USA, +1-201-***-****, *****.*********@*****.***, https://www.linkedin.com/in/vaishnavi

SUMMARY Regulatory Affairs professional with over 12 years of relevant experience in the pharmaceutical industry. Proven expertise in orchestrating global registration dossiers and authoring high-quality CMC documentation, ensuring compliance with international regulatory standards. Successfully accelerated approval times while collaborating with cross-functional teams to streamline submissions. Equipped with a strong foundation in regulatory processes

(eCTD, IND, NDA) and a commitment to delivering excellence that can significantly enhance operational efficiency and compliance in future roles. WORK EXPERIENCE

Apr 2021 – Present Senior Manager – RA CMC, Novartis Pharmaceuticals Corporation

East Hanover, USA

Facilitate support for cross-functional teams concentrating on the identification, planning, and execution of regulatory submissions. Compose and review high-quality CMC documentation for Health Authority submissions, establishing and applying global regulatory strategies alongside current regulatory trends and guidelines. Diagnose required documentation along with content, quality, and timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Orchestrated the compilation and submission of global registration dossiers, ensuring alignment with international standards and expediting approval times across regions utilizing digital regulatory tools. Aug 2017 – Apr 2021 Jr. Regional Brand Regulatory Manager, Novartis Pharmaceuticals Corporation

East Hanover

Collaborated with cross-functional teams focused on the identification, planning, and execution of regulatory submissions. Delivered operational and FDA submission coordination (publishing) support to global CMC managers and Clinical managers to ensure high- quality INDs, NDAs, DMFs submissions, and annual reports. Provided assistance to authors for the management of the document lifecycle in DMS.

Served as the primary liaison with DRA Operations to ensure precise and timely submissions to Health Authorities; monitored the tracking of submissions.

Acted as the single point of contact for Regulatory CMC discrepancies, ensuring timely follow-up and resolution, and reported outcomes to the data director.

Apr 2016 – Aug 2017 Sr. Submission Publisher – Regulatory Operations, Novartis Pharmaceuticals Corporation

East Hanover

Sep 2015 – Apr 2016 Regulatory operations Specialist, Target Health Ltd. New York City, USA Oversaw the management of the electronic submission XML backbone and electronic publishing for Target Health’s extensive client base. Directed the formatting, publishing, quality control, and assembly of electronic and/or paper submissions in appropriate formats (eCTD, NeeS, 510(k)) for submission to regulatory agencies, including INDs, NDAs, IND/IMPD/NDA Amendments and Supplements, and ODDs. Maintained standard operating procedures (SOPs) and training materials while assisting in the onboarding of new employees. Compiled final copies of regulatory submissions for distribution to regulatory authorities or other required parties.

Jan 2013 – Jul 2015 Regulatory operations Specialist, Novartis Hyderabad, India Formulated regulatory submissions utilizing specified processes, procedures, and systems.

Executed the processing of e-Submissions for US-FDA, EMA, Swissmedic, and RoW Countries; assisted the team in coordination, preparation, quality control, and submission of various dossiers in electronic formats worldwide

(eCTD and NeeS).

Spearheaded submission management by overseeing the end-to-end process of electronic submissions to optimize workflows. Evaluated submission history by compiling and analyzing data from past regulatory submissions over a specific timeframe to identify trends and enhance future submission strategies using specialized software. Supported the preparation of IND, CTA, NDA, BLA, and eCTD submissions in compliant output according to specified guidelines and requirements. Demonstrated expertise in ICH, US, and EU Regulatory Requirements concerning publishing formats like eCTD, NeeS, and 510(k) submission types.

Updated and executed training modules for the Regulatory team while revising SOPs for regulatory procedures.

EDUCATION

Jan 2010 – Jan 2012 SRM University

Master of Science, Pharmacy

Chennai, India

Jan 2006 – Jan 2010 Sri Ramachandra University

Bachelor of Science, Pharmacy

Chennai, India

SKILLS Regulatory Submissions Regulatory Affairs Project Management

Novstyle document writing Submission Management and Publishing Tools

RIMS (Regulatory Information

Management systems)

Document Management Systems

(DMS)

Regulatory Strategy Development

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