Regulatory Affairs Drug Development

SAI PRANATHI MEDA VENKATA, PhD

New Jersey (willing to relocate) • USA • 313-***-**** • *************@*****.*** I am a highly motivated and dedicated professional, with a deep passion and commitment to advance healthcare and make a meaningful impact on patient lives. I hold a PhD and a postdoctoral research expertise in pharmacology complemented by a masters in pharmaceutical regulatory affairs. I developed technical expertise, strong knowledge in immunology and communicate scientific data. My ability to interpret and communicate scientific data is exceptional and successfully contributed to securing a total of $ 721,252 in NIH grants. I have a strong record as a peer reviewer with 12 scientific publications. My background equips me with the skills necessary to excel as a regulatory affairs project lead, where I aim to leverage my expertise to support advancements in health care and improve patient outcomes.

KEY SKILLS

Peer reviewing

FDA, EMA,PMDA Regulations

Medical device regulations

Clinical trials

Submission processes for IND,

NDA,CTA,MAA, and BLAs

eCTD Filing

Clinical trial protocols design and GCP

510(K) Notifications

Scientific communication

Regulatory compliance

Strategic planning

Six Sigma/Lean concepts

CAPA

Medical Writing

Knowledge of rare diseases

Strategic vision and thinking

Project management

Leadership

Scientific mentoring & training

Grant/manuscript writing & editing

Risk-benefit assessment

Cross functional communications

Problem solving

Drug development

Health outcomes research

Microsoft Office Suite

R programming, SPSS, JMP

BSL2/BSL3 practices

Data handling and statistical analysis

PROFESSIONAL EXPERIENCE

Scientific Journal Peer Reviewer Feb 2020 - Present

• Critically evaluated over 41 research manuscripts for the following journals for scientific accuracy, methodological rigor, and relevance, demonstrating expertise in data analysis, critical thinking, and effective communication of complex scientific concepts:

Healthcare ; International Journal of Environmental Research and Public Health (IJERP) ; International Journal of Molecular Sciences (IJMS) ; Cardiovascular Diabetology, BMC ; Diabetes, Metabolic Syndrome and Obesity Targets and Therapy; Dove Press ; Cells ; Applied Biosciences ; Diabetology ; Nutrients ; Sustainability ; Indian Journal of Pharmaceutical Sciences Postdoctoral Research Fellow University of Michigan, Ann Arbor Aug 2022 - Present

• Published 10 research papers, peer reviewed 41 research papers in renowned scientific journals

• Mentored 6 PhD students and 4 undergrads

• Experience and confidence working with cross functional teams, providing research and advice on SOP preparations, updated good laboratory practices

• Strategic thinker with strong attention to detail, ability to multitask and establish and maintain good working relationships with excellent communication skills

Graduate Research Assistant Wayne State University, Detroit Aug 2018 - Jul 2022

• Presented scientific research at 6 national and 3 international conferences, showcasing excellent communication skills to different audiences.

• Led cultivation and communication of medical knowledge in related therapeutic areas and maintained up-to- date knowledge of global medical research to achieve team goals

• Prepared submission documents and secured IACUC approval for several research protocols Managed safety tests as part of Radioactive Safety Committee, and leveraged analytical problem-solving and decision-making skills to promote efficient research environment Regulatory Affairs Associate, Dr. Reddy’s Laboratories LTD. Hyderabad, India Jul 2016 – Feb 2018

• Managed regulatory document lifecycle for various medical device submissions, demonstrating expertise in IND, BLA, and NDA processes, as well as license renewals and labeling updates.

• Prepared Pharmaceutical Regulatory dossiers for emerging markets in Africa, Asia, Latin America and Middle East, and handled e-CTD submissions for Europe and the USA. Developed timelines, milestones, and resources for regulatory submissions, ensuring compliance with local and international regulations

Dissertation: ‘Comparison of regulatory requirements with special emphasis on bioequivalence guidance’s for registration of generic drug products in USA, Japan, China, India and South Africa.’ EDUCATION

Wayne State University Detroit, MI Aug 2022

Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences JSS Academy of Higher Education and Research Mysuru, India Master of Science (M.S)., Pharmaceutical Regulatory Affairs Jul 2018 P.G. Diploma., Pharmaceutical Nanotechnology May 2018 Bachelor of Science (B.S)., Pharmacy Jul 2016

PUBLICATIONS

• Meda Venkata SP, HS A. Nano Theranostics – a breakthrough in cancer diagnosis and treatment and regulations of nano technology products. International Journal of Pharmaceutical Sciences and Research. 2018

• Meda Venkata SP, M.P. Venkatesh, T.M. Pramod Kumar, Suman Shekar. Medical Devices Warning Letters: Trend Analysis form 2011 – 2016. Elixir International, 2017.

• Meda Venkata SP, Balamuralidhara V, Mahalakshmy R. Regulation of controlled drug substances in SAARC Countries. International Pharmaceutical Industry, 2017..

• Meda Venkata SP, Li H, Xu L, Koh JY, Nguyen H, Minjares M, Li C, Kowluru A, Milligan G, Wang J.Inhibition of GPR39 restores defects in endothelial cell-mediated angiogenesis under the duress of chronic hyperglycemia: Evidence for novel regulatory roles of the Sonic Hedgehog signaling axis. Proceedings of National Academy of Sciences (PNAS) USA. 2023 Jan 3;120(1): e2208541120. PMID: 36574661

• Full list of publications on google scholar: https://scholar.google.com/citations?user=ej6go_gAAAAJ&hl=en ORAL PRESENTATIONS

Oral Presentations:

• The role of G Protein-coupled Receptor (GPR39) in regulating mitochondrial function, Cardiovascular research institute meeting (CVRI), 2019

• Deletion of G Protein-coupled Receptor 39 (GPR39) improves endothelial cell function in Type 2 diabetes, GWIS Annual Meeting, 2021

• Deletion of G Protein-coupled Receptor 39 Protects angiogenesis in hyperglycemia, American heart association scientific sessions, 2021

• Epileptic encephalopathy mutations in Gao impair interactions with NeuroFibromin 1 (NF1), Gordon Research Conference, 2024

• Current and Future Trends of Medical Devices in India, 67th Indian Pharmaceutical Congress scientific sessions, 2015

LEADERSHIP AND ORGANISATIONAL EXPERIENCE

• Vice President - American Association of Pharmaceutical Scientists (AAPS), WSU Chapter 2018-2021 Recruited members, participated, and audited different activities with emphasis on developing products and therapies to improving global health.

• Organizer-Signal transduction journal/Data club, University of Michigan 2022- Present Recruit members, invite and schedule guest speakers, and host a biweekly space for discussion of current literature in the field for an interdepartmental group of 60 active researchers at the university.

• Mentor -Trained 4 Summer Undergraduate Research Fellowship (SURF) program trainees, 6 PhD students, University of Michigan-Medical School -2023

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