Regulatory Affair

Patel Sweety

Contact No: '570-***-**** E-mail: ***************@*****.***

Objective:

With my vast experience, seeking opportunity in Pharmaceutical, clinical research, healthcare industry to utilize and expand related education, skills, experience and capabilities.

Professional Summary:

Extensive knowledge of current regulatory guideline, SOP preparation, study development, good clinical and documentation practice (ICH-GCP).

Accustomed to working with project management teams and other internal department.

Flexible and adaptable to change with learning attitude along with integrity and team work.

Fast learner with the proven ability to hit the ground running and deliver results quickly.

Computer experience- MS Office (Word, Power Point, Excel, Access), MS Outlook, Lotus Notes, Windows 7/ Vista/ XP

Fluent in English, Hindi, Gujarati.

Education:

The University of Findlay, Findlay, Ohio Graduated : Dec’08

Master of Business Administration – Health Care Management

Rajiv Gandhi University of Health Science, Bangalore, India Graduated : Apr’06

Bachelor of Pharmacy

Professional Experience:

Regulatory Affair Officer at Synchron Research Services Pvt. Ltd, India

Mar’ 2014 – Jan’ 2017

Responsibilities:

Responsible for planning and execution of the BA-BE studies along with coordination with internal teams as well as related stakeholder like sponsor, clinical investigator, IRB/IEC, State and Indian Regulatory authorities.

Highly involved in prepare, manage or maintain simple and complex regulatory submission/dossier by paper and electronic for IND, NDA, ANDA products, notification, amendment, annual reports, etc. to CDSCO, Independent Ethics Committee, Central Bureau of Narcotic independently as per current regulatory guideline along with basic knowledge of eCTD submission.

Responsible for submission has been published with high quality standard and obtaining the permit from regulatory authority to conduct study as per sponsor’s timeline

Working in collaboration with internal department like Clinical, Quality Assurance, Pharmacy and Purchase to execute the projects in most timely manner

Prepare and review SOPs (Standard Operating Procedures), ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.

Prepare dossier and regulatory/study documents such as Trial Master File, Renewal of Facilities licenses, Adverse/Serious drug Event report, USFDA 1572 forms and etc.

Responsible to provide the appropriate answer to any inquiries have been generated from regulatory bodies within applicable timeline and provide support to clinical department during time of audits from various regulatory bodies.

Rigorously follow up on daily activities and assist respective team as and when require

Proactively coordination between company and sponsor including but not limited to study documents review & finalization, obtaining require regulatory/study specific documents, study update to sponsor, attend & assist to resolve regulatory queries received from different regulatory bodies etc

Work intensively to provide the clinical dosing schedule, end of study report, and follow-up report of Adverse/Serious Event and etc on time to the respective authorities.

Project Coordinator at Lincoln Pharmaceuticals Ltd, India Jul’ 2011 – Feb’ 2014

Responsibilities:

To take initiative and read latest regulatory guideline on dossier requirement/discuss with manager before dossier submission and upgrade dossier checklist accordingly to past queries/response for submission to CDSCO.

Review adequately and accurately of regulatory documents received from manufacturing unit by coordinating with Plant QA, production, packing, Project coordinator, etc

Update and maintain document archival system after submission of the dossier to the drug authority a soft copy of the same to be maintained in order to have backup of the dossier submission

To prepare quarterly report on plan vs. actual and track the submission by interacting outside experts or regulatory agencies.

Volunteering at Palisade Hospital, North Bergen, NJ Jul’ 2008 – Oct’ 2009

Responsibilities:

Extensively performed initial screening or eligibility determination and insurance verification of all uninsured or underinsured patients, both in-house and after discharge.

Highly responsible and ready to take initiative for making decisions on routine problems and working with their Manager with non-routine questions.

Successfully created accounts for patients and verified insurance as requested and checked benefits and eligibility of treatment.

Corrected prepared and submitted claims to insurance carriers and made accounts private and notified patients when claims had not been paid after time frames in established self pay procedure/process.

Involved in preparing folders, verifying accuracy of medical record number to patient identifier and maintained records of newly admitted patients. Kept the files and records of current and past patients with up-to-date information.

Carefully maintained confidentiality of all information to ensure fulfillment of HIPAA, OSHA, JCAHO and EMTALA compliancy standards.

Working knowledge of quality improvement principle and methodologies in health care. Ability to assess and to explain data from broad perspective.

Additional:

Internship: One month of internship had been completed at Scion Pharma Pvt Ltd., India

Training: Received training of GCP had been organized by ACRO India in 2016

References

Will be provided on request

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