Profile Details

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Hire Neeti S.

India

USD 15 /hr

Masters in Pharmacy with 10 +years of experience in Drug Regulation and Policy Advocacy for Pharma & Medical Devices

Profile Summary

Regulatory professional with 10 years of, experience. More than eight of which within drug regulatory affairs in CDSCO National Drug Regulatory Authority of India. Broad experience of scientific writing, regulatory expertise in review of SAE (Serious Adverse Event) Reports and writing medically relevant safety narrative of case, driving both in successful CTA and IND submissions and the preparation of technical dossiers submission of New Drug Application, Post Approval Applications. Ability to manage through complex global regulatory submissions with global health authorities including FDA, EMA, Professional Experience Presently working FICCI for Life Sciences Division (Pharma and Biotech) since June 2019 and for Medical Devices Division, in FICCI, Delhi from July 2018-June 2019. Job profile: • Work on knowledge output on Sector – reports published by FICCI, industry representations to government stakeholders like NPPA, Department of Pharmaceuticals, GoI, MoHFW presentations on thematic areas • Develop concept notes/ proposals for projects, thematic discussion papers • Develop and maintain documents templates and high-quality systems for tracking regulatory submissions, reports for policy briefs and representations, work on stakeholder consultations and meetings for policy discussions, provide policy feedback to relevant government in a structured manner. • Execute outreach events and delegations, work with team to develop concept notes, budgets, agenda for events Coordinate, guide and assist in external communications work and day-to-day internal communications • Participate in various task force activities of Pharma committee and project meetings related to area(s) of responsibility. • Implements all activities related to the preparation of e.g. abstracts, posters/ presentations, manuscripts or to the preparation and compilation of data and information into a single comprehensive package for pharma sector. • Provide scientific expertise to sectoral team in the development of new business proposals like Proposal under Pharmaceutical Product Development Scheme to Department of Pharmaceuticals, MoCF, GoI • Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents for Pharma sector specific issues. Worked as Technical Data Associate, at Drug Controller General of India, CDSCO-Head Quarter, MoHFW, Kotla Road, ITO, Delhi (Related to Regulatory Affairs and Manufacturing of vaccines and Drugs, Medical Devices & Diagnostics in India) as per provisions of Drugs and Cosmetics Act, 1940 since January, 2010 to June 2018. Job Profile: • Review of regulatory documents such as those associated with filings and dossiers, pertaining to clinical trials, market authorization, new drugs approval, clinical trial approval, BA/BE study approval this included study of investigation of clinical study reports, clinical study protocol, annual reports, investigator brochures, case record form, stability study data and other relevant manuscripts. • Handling of SAE (Serious Adverse Event) Reports and writing medically relevant safety narrative of case and checking the completeness of case, along with verification of the information/documents submitted by sponsor, investigator and ethics committee for the relatedness / non-relatedness of SAE that occurred during conduct of clinical trial, calculation of compensation amount to be paid to legal heir of subject/ subject as per provisions of Drugs and Cosmetics Rules 1940 along with verification of the information/ documents submitted by Sponsor, Investigator and Ethics Committee to make sure that the submission of data was done according to Schedule Y of D&C act, 1945 and identification of protocol deviations, misconducts during the clinical trial and Calculation of the compensation to the subject/ legal heir/ nominee as per 122 DAB and Appendix-XII of Schedule Y to Drugs & Cosmetics rules 1945, in case of SAE related to the Investigational product/ clinical trial. • Scrutiny of applications pertaining to Import and Registration as per provisions of Drugs and Cosmetics Act, 1940 and Rules there under • Evaluation of Bioequivalence and Clinical Trial Protocol and their reports, summarization of clinical data. • Scrutiny of applications pertaining to Additional Indications, Additional Strengths, New Dosage Form, Package Insert Update, Ethics Committee Registration, PSURs, Post Marketing Surveillance Reports • Prepare evaluation reports and summaries highlighting the regulatory & technical issues and deficiencies in the submission documentation for further evaluation by Drugs Inspectors and Asstt. Drugs Controllers. • Preparation of the permission and drafting the queries letter and correspondences to the applicants. • Contribute in preparation of Guidance documents, SOPs, Checklist. Worked as Lecturer (D. Pharmacy) from July 2006 to August 2007 at B.S. Anangpuria Institute of Pharmacy, Faridabad, Haryana. Job Profile: • Deliberating lectures(theory) and conduct of Practical classes

Subject Matter Expertise

• ★ Medical Writing
• ☆ Regulatory Affairs

Services

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Fact Checking, Systematic Literature Review

Data & AI Statistical Analysis

Work Experience

AD

FICCI

June 2018 - Present

TDA

CDSCO

January 2010 - June 2018

Lecturer

BSAIP Haryana India

July 2006 - August 2007

Education

Masters in Pharmacy

DIPSAR

August 2007 - August 2009

Certifications

• Certification details not provided.