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Srinivas Nerella Phone : 978-***-****.

Email: advlow@r.postjobfree.com Linkedin: www.linkedin.com/in/srinivas-n-b7a7508a PERSONAL STATEMENT.

Regulatory affairs professional experienced in Regulatory Strategies, 21 CFR, Regulatory Compliance, CMC Regulatory Affairs, SOP, Clinical Trials and Validation, Design control, ISO, Product Development & Advertisements. Solid working knowledge of Regulatory Submissions, Product labeling, Quality Assurance & Quality Systems, eCTD, GMP, GCP, GLP, Documentation, and Docketing. TECHNICAL SKILL

Medical Device: 510(k), IDE, PMA, UDI, MDRs, ISO 13485, ISO 14971, DMR, DHR, DMF

Drugs and Biologics: pre-IND, IND, DMF, NDA, BLA, MAA, ANDA, Regulatory Submissions

Compliance Audits: FDA Form 483, Warning Letters, Consent Decrees, GMP, GLP, GCP,, CAPA, 21 CFR, and Labeling compliance, Informed Consent, Protocol preparation, and review EDUCATION.

Master of Science (MS) in Regulatory Affairs (2022) from Northeastern University-Boston. Master of Science (MS) in Organic Chemistry (2013) from Mahatma Gandhi University-Hyderabad. Bachelor of Science (B.Sc) in Chemistry, Bio-Technology and Microbiology (2011) from Kakatiya University- Warangal.

PROFESSIONAL EXPERIENCE.

OFFICER . (April-2019 to March-2021)

VIATRIS, HYDERABAD, INDIA.

Prepares and submits international product registration documentation for various classes of medical devices.

Support and prepare US and EU medical device submissions.

Implement the update of technical documentation from MDD to MDR for existing products.

Responsible for providing worldwide pre-market and post-market regulatory affairs support for medical devices.

Maintain regulatory systems to ensure data integrity, resolving data inconsistencies and producing various reports as needed.

Ensure compliance with the design control process and with the QMS.

Responsible for post-market surveillance and revision of related risk management as applicable.

Review product/manufacturing process changes, supplier changes, new and revised engineering protocols, and reports, and reviewing product labeling updates.

Working cross-functionally seamlessly and ensure alignment on different project and status. SENIOR CHEMIST. (April-2016 to March-2019)

MYLAN LABORATORIES LTD, HYDERABAD, INDIA.

Coordinate, prepare or maintain regulatory filings or submissions to obtain and sustain product approval 2

Maintain, track, and update regulatory documentation.

Develop and maintain technical documentation (technical files) required for regulatory compliance with EU MDR.

Review US regulatory data and documentation according to international standards.

Provide support for internal and Regulatory Agency audits

Read and analyze FDA regulations and policies, articles in scientific, technical journals, and legal documents

Check the status of variants using regulatory document management systems. CHEMIST . (Feb-2014 to March-2016)

MYLAN LABORATORIES LTD., HYDERABAD, INDIA

Preparing Literature search report, Rout of synthesis Disclosure, Freedom to operate, Patent analysis, and legal status for the concerned patent(s)/ patent application(s) in various countries.

Communication with attorneys from law firms in the United States, Europe, and other countries for patent litigation and office proceedings.

Preparing Literature search report, Rout of synthesis Disclosure, Freedom to operate, Patent analysis, and legal status for the concerned patent(s)/ patent application(s) in various countries..

Prepares and oversees documentation packages for submission to global regulatory agencies. ACADEMIC PROJECTS

Mock 505(b)(2) submission: Prepared, reviewed and submitted a mock 505 (b) (2) application for a new drug as a part of course work in USA.

Mock 510(k) submission: Prepared, reviewed and submitted a mock 510 (k) application as a part of course work Prepared and presented the regulatory pathway for approval of Medical Devices and drugs in U.S and EP as part of coursework.

Prepared and submitted a mock clinical protocol, Informed Consent Form and Investigation New Drug Application using eCTD format.

CAPSTONE PROJECT:

Prepared, reviewed and submitted an Emergency use authorization for Covid-19 drug for Sen-Jam pharmaceutical.

IT SKILLS.

MS Word, PowerPoint, Excel, Docketing and Outlook. CERTIFICATIONS

Intellectual Property Rights course from University of Pennsylvania.

Base SAS certified programmer.

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