Jay Gutta
Regulatory Affairs Specialist
Phoenix,AZ
Summary
Knowledgeable Pharmacist who is a regulatory affair's specialist with five years of experience in health care and clinical research industry. Enthusiastic and eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of Clinical Research and training in Regulatory Affairs. Motivated to learn, grow and excel in Clinical Research Industry.
Overview
7
7
years of professional experience
8
8
years of post-secondary education
4
4
Certifications
Work History
Regulatory Affairs Specialist
Az Heart Rhythm Center
Phoenix, AZ
04.2022 - Current
- Coordinated clinical trials focused on Cardiovascular Medical devices.
- Negotiated and facilitated Clinical trial agreements, budgets including master CTA's with medical device companies like Edwards, Corvia medical, Impulse Dynamics, Cordis, V-Wave.
- Activated ten trials within six months and another six trials close to activation. One trial at a record time of three weeks between filling the site qualification and site activation including CTA, Budgets and IRB approvals.
- Maintained up to date IRB status and submitted all kinds of IRB submissions for both cental IRB and local IRB.
- Responsible for setting up the trial including the source docs preparation and preparing a process flow for the study coordinators to follow after the site activation.
- Participated in interim monitoring visits and made sure all the action items in the follow up letter are completed with in one week.
- Maintained and archived regulatory paperwork.
- Performed and documented quality control checks to maintain compliance with Site, Sponsor and IRB requirements.
- Developed or tracked quality metrics of Clinical Research Coordinators.
- Wrote or updated standard operating procedures, work instructions or policies.
- Successfully implemented CTMS CRIO system for all the trials at the site.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Performed Clinical trial visits when required.
Regulatory Affairs Consultant - Contract
E-Nexus Inc
Boston, MA
09.2020 - 04.2022
- Worked as a clinical study startup specialist and Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Offered friendly and efficient service to customers, handled challenging situations with ease.
- Contracted with several companies with mediating CTA's, Budgets and study startup activities and prepared a detailed project plan to follow.
- Built the clinical studies into CTMS including financials and Esource.
- Resolved conflicts and negotiated mutually beneficial agreements between parties.
- Prepared and submitted regulatory file applications and supporting documentation.
- Prepared and maintained document inventory for core dossier preparation.
- Represented company in Biologic's industry during communications with global regulatory agencies.
- Used Insight publisher, ISI tool box, Lorenz validator to create product technical file packages for global product compliance certifications of drugs and biologic products.
- Responsible for document control duties by initiating, planning, monitoring and posting new and/or changed regulatory documents.
- Managed technical tools in regulatory areas including documentums and publishing systems like Veeva vault, Insight publisher, ISI toolbox., eCTD express, eCTD manager and Lorenz validator.
- Worked in CMC department in maintaining life cycle submissions of several biologic and small molecules including PAS, Annual Reports.
- Authored and prepared dossiers of pre approval supplements and post approval lifecycle management submissions
Project Manager/Business Finance Manager
GGK Constructions
New Delhi , India
01.2018 - 12.2020
- Developed and initiated projects, managed costs and monitored performance.
- Met project deadlines without sacrificing build quality or workplace safety.
- Facilitated communication between internal personnel, contractors and vendors for project cohesion.
- Led project teams through design, construction and launch process.
- Achieved project deadlines by coordinating with contractors to manage performance.
- Modified and directed project plans to meet organizational needs.
- Managed projects from procurement to commission.
Drug Safety Associate (Phase IV Clinical Trials)
Gucons Pvt LTD
Hyderabad, India
06.2018 - 08.2019
- Navigated intricacies of drug safety databases to process adverse event reports.
- Communicated with internal or external contacts to resolve issues related to case processing.
- Compared adverse event source documents against safety database screens for transcription and medical accuracy.
- Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.
- Oversaw adverse events case reporting and conducted follow-up.
- Reviewed, compiled and analyzed data for safety database management.
- Evaluated safety profiles, wrote signal detection reports and monitored document filing and archiving.
Clinical Pharmacist Intern
NRI Medical College And Hospital
Guntur, India
05.2017 - 04.2018
- Educated patients on possible drug interactions, potential side effects and optimal methods of administration.
- Discussed medical histories with patients to provide most effective medical advice.
- Evaluated patient histories to assess medication compliance and spot issues such as doctor shopping or excessive usage.
- Counseled patients on new medications and OTC products.
- Worked in different medical departments as a pharmacist intern and helped physicians to provide best medical care possible.
- Verified prescription information against safety guidelines to protect patients health and safety.
- Worked on drug information queries raised by physicians
Clinical Clerkship
NRI Medical College And Hospital
Guntur, India
11.2016 - 04.2017
- Analyzed prescribing trends and refill trends to monitor patient compliance and prescribing practices.
- Advised patients on potential adverse effects and drug interactions.
- Worked on academic project on pharmacovigilance analysis of proton pump inhibitors.
Education
Master of Science - Clinical Research
Ohio State University
Columbus, OH 08.2020 - 08.2021
Master of Science - Project Management
Northeastern University
Boston, MA 01.2019 - 12.2020
Pharm.D - Doctor of Pharmacy
Acharya Nagarjuna University
India 11.2012 - 04.2018
Skills
Project Management
FDA Regulations
Clinical Trial Operations
Regulatory Operations
Clinical Study Startup
Pharmacovigilance
Agile Project Management (SCRUM)
Contract Negotiation
MS Project
Adobe, ISI toolbox, ECTD manager, Insight Publisher
IRB Submissions
Clinical Research monitoring
Regulatory Authoring
Regulatory Document Publishing
GCP
Certification
CITI - GCP
Timeline
Regulatory Affairs Specialist
Az Heart Rhythm Center
04.2022 - Current
Regulatory Affairs Consultant - Contract
E-Nexus Inc
09.2020 - 04.2022
Master of Science - Clinical Research
Ohio State University
08.2020 - 08.2021
Master of Science - Project Management
Northeastern University
01.2019 - 12.2020
Drug Safety Associate (Phase IV Clinical Trials)
Gucons Pvt LTD
06.2018 - 08.2019
Project Manager/Business Finance Manager
GGK Constructions
01.2018 - 12.2020
Clinical Pharmacist Intern
NRI Medical College And Hospital
05.2017 - 04.2018
Clinical Clerkship
NRI Medical College And Hospital
11.2016 - 04.2017
Pharm.D - Doctor of Pharmacy
Acharya Nagarjuna University
11.2012 - 04.2018