Dr. Srisha R Email & Phone Number

Cumming, GA, US

Augusta, Georgia, United States

• Spearheaded a 30% improvement in internal and external communication processes for product stewardship and regulatory affairs documentation, enhancing response times and consistency across customer/supplier.
• Elevated data integrity and documentation accuracy by 25% by overseeing product stewardship records, including SDS, regulatory filings, labels, EPA CDX reporting, and REACH dossiers, ensuring comprehensive regulatory.
• Optimized regulatory compliance efficiency by 40% through implementing enhanced product stewardship and safety risk management programs, in close collaboration with operations, quality, EHS, shipping, commercial, and.
• Created and delivered training programs that reduced documentation redundancies by 20%, empowering teams with essential knowledge and reinforcing product stewardship best practices.
• Streamlined compliance documentation for government approvals of fluorochemicals, increasing reporting accuracy and reducing preparation time by 35% across pre- and post-market surveillance (EPA TSCA, REACH, foreign.
• Achieved 100% on-time submission of annual stewardship and regulatory reports (e.g., EPA TSCA, AIMS Act, REACH), maintaining regulatory transparency and meeting compliance deadlines.

Canada

• Internship project in collaboration with Northeastern University Experiential Network (XN) and Crown College of Canada
• Internship Supervisor: Professor Peivand Pirouzi, P.h.DResponsibilities:
• Successfully prepared various submission documents and used the CTD backbone to meet Health Canada's validation criteria for the preparation of CTD submissions, ensuring full compliance with Canadian and International.
• Interpreted and applied ICH-M4, and Health Canada's regulations, guidance documents, and policies, and used them to effectively prepare, compile, and format regulatory documents by regulatory guidelines.
• Collaborated effectively within the team to coordinate the compilation of necessary documentation, ensuring seamless information exchange and timely completion of regulatory submissions.
• Proactively acquired and applied Regulatory Project Management skills, including the utilization of tools such as Gantt charts, to ensure efficient planning and execution of submissions in CTD format, resulting in.

Ell Hall- Neu Campus

Burlington, Massachusetts, United States

• Assisted the business in the execution of daily tasks, including planning and preparation of Investigational New Drug Application (IND), New Drug Application (NDA), and other documentation for submission to the US Food.
• Authored IND for a Drug-Device Combinational product. Authored various subsections of the IND which includes M1,M2,M3,M5 for USFDA submissions. Profound expertise in the clinical, non-clinical, Drug substance, Drug.
• Assisted in various Regulatory Submissions for the USFDA including PAS, CBE-30, Annual Reports and DSUR.
• Performed QC for essential Regulatory document Submissions.
• Assisted in the various FDA interactions like template preparation, taking meeting minutes, and preparation of Draft for Sponsors minutes to FDA.
• Supported program teams in the preparation and conduct of milestone meetings with FDA and other key stakeholders to seek advice and gain agreement on regulatory requirements for critical development initiatives.

Vellore, Tamil Nadu, India

• Active member of the antimicrobial stewardship committee in the hospital, by assessing prescribing patterns and optimizing the use of antibiotics in the Paediatric population..
• Performed pharmacovigilance activities by reporting adverse drug reactions to the Uppsala Monitoring Centre in the dermatology department.
• Actively counselled outpatients in vernacular languages where treatment adherence was quintessential like an autoimmune condition or Paediatric neurology prescriptions.
• Evidence-based drug information was provided to healthcare professionals as and when needed.
• Effectively trained fellow hospital pharmacists by providing lectures on topics related to health care that helped to upgrade themselves in the hospital.

Bengaluru, Karnataka, India

• Received extensive training to perform pharmacovigilance activities for case processing.
• Contributed to processing cases for Johnson and Johnson company.Highly motivated and works with multiple teams.
• Possesed extraordinary communication and presentation skills.

India

• Provided lectures on topics related to Pharmacotherapeutics and Pharmacology to Doctor of pharmacy students.
• Provided intensive training to Pharm D internship students to perform various clinical care activities in a hospital as a clinical pharmacist.

India

• Completed rotations in various departments like orthopedics, pediatrics, surgery and general medicine
• Performed clinical pharmacist activities like identifying drug - drug interactions, dosage modification in renal and hepatic failure, reporting of adverse drug reactions.
• Proficient in using Micromedex and Idis software. Drug information and counseling services to patients.

Master Of Science - Ms, Regulatory Affairs, A

•Medical device approval pathways, classification of medical devices, 510(k) submission, medical device reporting, Investigational Device.

Doctor Of Pharmacy (Pharmd), Pharmacy

I have completed my 6 years of course period which includes five years of study period and 1 year of internship in various wards in the.