Shivani
Jamshedpur
Summary
Dynamic Senior Regulatory Affairs Specialist with extensive experience of three years at PPD, part of Thermo Fisher Scientific. Proven track record in regulatory submissions (in EMEA, under both EU CTD and EU CTR, and APAC and LA region) and strategic planning, demonstrating strong analytical skills and leadership. Adept at ensuring compliance and fostering client relationships, while quickly adapting to new challenges in fast-paced environments. Innovative Regulatory start-up specialist with an experience of 6 years with a background in identifying profitable opportunities and driving business growth. Familiarity with developing strategic partnerships, securing funding, and building cross-functional teams to support start-up operations. Strong leadership skills with emphasis on ability to motivate team members and foster collaborative work environments. Proven track record in transforming innovative ideas into successful businesses, contributing significantly to corporate success.
Overview
10
10
years of professional experience
Work History
Senior Regulatory Affairs Specialist
PPD, part of Thermo Fisher Scientific
03.2022 - Current
- Preparation and review for regulatory submission (both Part I and Part II dossier under EU CTR).
- Preparation and review of regulatory submissions, mainly Initial Clinical Trial Application (CTA), Amendments, End of Trial, CSR, etc., for all regions (APAC, EMEA, LA, NA).
- Liaise with internal and external clients in the tracking and status update of project plans. Explain the process to the client, with presentation and timelines.
- Plan regulatory strategies for regulatory submissions.
- Evaluate risk and considerations during the project life on regulatory aspects.
- Preparation, review, and provision of ethics committee applications and health authorities for clinical trials, based on the protocol, investigator brochure, and available information, to ensure timely approval of clinical trials.
- Preparation, review, and approval of periodic reports to the ethics committee and health authorities. Review and approval of proposed packaging and labeling for clinical trial material to ensure compliance with local regulations.
- Preparation, review, and submission of importation and/or exportation licenses and/or permits for clinical trial materials, in accordance with local requirements.
- Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
- Ensure compliance with appropriate global regulatory requirements, and the company's policies and processes.
- Prepare training materials and share best practices in the regulatory area, both internally and externally.
- Participate as regulatory support in internal or external project audits.
- Participate as regulatory support on internal, cross-functional initiatives.
Senior Regulatory and Start up Associate
Novotech CRO
07.2021 - 11.2021
- Preparation, review, and provision of ethics committee applications and health authorities for clinical trials, based on the protocol, investigator brochure, and available information, to ensure timely approval of clinical trials.
- Preparation, review, and approval of periodic reports to ethics committees and health authorities.
- Review and approval of proposed packaging and labeling for clinical trial material to ensure compliance with local regulations.
- Preparation, review, and submission of importation and/or exportation licenses and/or permits for clinical trial materials, in accordance with local requirements.
- Preparation, customization, and review of the Patient Information Sheet/Consent form in accordance with ICH GCP and local requirements.
- Review, comment, and approval of activation packages for the release of the investigational product.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
- Participated in team-building activities to enhance working relationships.
Regulatory and Start up Specialist I
IQVIA
09.2015 - 06.2021
- Serve as cRSU Lead/Single Point of Contact (SPOC), and be the primary interface between the Regional Regulatory Start-Up Lead and the local (country-specific) RSU Specialist in Asia Pacific countries.
- ICF: Development/customization of Main and Non-Main ICFs according to the country and site regulatory, and GCP requirements in the APAC region.
- Preparation of ethics committee applications for clinical trials, based on the protocol, investigator brochure, and available information, specialized for Australia, New Zealand, and India.
- Compilation and review of EDP and IP release activities.
- Act as a Subject Matter Expert (SME) and internal QC reviewer for the ICF adaptation and submission process.
- Well-versed in various system tools, such as CTMS, eTMF, EEL, SharePoint, and the Investigator portal, etc.
- Budget preparation for the country and sites using the Grant Plan application for APAC.
- Customization and review of the CTA: incorporating the approved budget and country requirements.
- Mentor for the new joiners on the different cRSU scope of work.
Education
B-tech - Biotechnology
DR MGR Educational And Research Institute
Chennai, TN01.2013
Skills
- Flexibility
- Excellent verbal and communication skills
- Good analytical and reasoning skills
- Integrity
- Team member
- Leadership
- Adaptability
- Quick learner
- Dexterity
Websites
Hobbies and Interests
- Swimming
- Driving
- Reading
- Travelling
- Listening to Music
- Dance
Languages
- English
- Hindi
Accomplishments
- In ThermoFisher: Had received recognition for understanding the clients' needs and timeline, and for making the submission under EU CTR submission within an admirable time.
- In IQVIA: Had been awarded the Star performer for doing the most EDP-RC approval in order to have the site activation faster.
Timeline
Senior Regulatory Affairs Specialist
PPD, part of Thermo Fisher Scientific
03.2022 - Current
Senior Regulatory and Start up Associate
Novotech CRO
07.2021 - 11.2021
Regulatory and Start up Specialist I
IQVIA
09.2015 - 06.2021
B-tech - Biotechnology
DR MGR Educational And Research Institute
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