Srisha Rajasekar

I am a Doctor of Pharmacy Graduate( Pharm D) with past experience as a drug safety associate, clinical Pharmacist, and clinical trial coordinator who is currently pursuing an MS in Regulatory Affairs degree at Northeastern University, Boston, MA, United States. I have work experience in the USA market as I am working at a firm as a Regulatory Affairs co-op for a Drug-Device combinational product.

Sc Pharmaceuticals USA

Regulatory Affairs Co-op

• Assisted the business in the execution of daily tasks, including planning and preparation of Investigational New Drug Application New Drug Application (NDA), and other documentation for submission to the US Food and Drug Administration (FDA).
• 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 product and Administrative sections.
• Assisted in various Regulatory Submissions for the USFDA including PAS, CBE-30, Annual Reports and DSUR.
• Assisted in the various FDA interactions like template preparation, taking meeting minutes, and preparation of Draft for Sponsors minutes to FDA. 
• Performed QC for essential Regulatory document Submissions.
• 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.
• Gained extensive knowledge about device components, Various ISO guidance documents, Change control review boards, CAPA, SCAR, Quality requirements, Device engineering, and CMC requirements.
• Tracked project timelines and coordinated with subject matter experts to address complex questions in a timely manner while ensuring the highest standard of quality.

Clinical Pharmacist

• Collaborated with internal stakeholders to develop and enhance regulatory processes and procedures, led to a 20% reduction in submission timelines.
• Inspected adherence to CMC, GCP, and SOP for the in-hospital manufacturing unit resulting in 40 % compliance deviation.
• Spearheaded preparation of regulatory dossiers for quality, led to a significant 15% reduction in approval time.
• Mentored and trained other professionals to ensure compliance with regulatory requirements on clinical trial sites.
• Devised and executed protocols and achieved a flawless 100% approval rate from Institutional Review Boards (IRBs) for prospective and retrospective clinical trials.
• Prepared briefing documents and other regulatory submissions resulted in 100% approval from regulatory authorities.
• Implemented clinical pharmacy strategies in intensive care units, resulting in a notable 40% reduction in medication errors.

Safety Associate Trainee

• Evaluated and assessed individual case study reports (ICSR) based on seriousness, and special situations received from clinical trials reports for Xarelto (rivaroxaban) with timely communication with Johnson & Johnson.
• Drafted accurate and concise narratives in the SCEPTRE safety database to capture patient demographics, ADRs, treatment drugs, and seriousness from MedWatch forms along with coding of medical history and adverse event terms using MedDRA.

Clinical Trial Coordinator

• Collaborated in the informed consent process including interactions with IRB, and discussions with research participants, including with research participants, including answering any questions related to the protocol.
• Monitored, verified, and archived Clinical Trial Master File. Entered data and status updates in the Clinical Trial management system.
• Approved site procedures, validation protocols, and reports according to ICH-GCP.
• Achieved seamless coordination with research coordinators, resulting in 100% accuracy and transparency of data.

Northeastern University - Boston, MA USA

Master of Science in Regulatory Affairs||GPA 4/4

Coursework: Regulatory Compliance, Strategy, Product Development, CMC, Submissions, FDA and ICH Guidelines

Past

The Tamil Nadu Doctor MGR Medical University -INDIA

Doctor Of Pharmacy (Pharm D) || GPA: 3.8/4

Coursework: Jurisprudence, Formulation, Medicinal Chemistry, Pharmacoepidemiology, and Therapeutics.