GAYATRIGARG

Mobile No.: +91- 9643643959 E-mail: gayatrigarg9999@gmail.com

Brief Summary

A passionate and enthusiastic drug regulatory professional, pharmacy postgraduate with 8 years of experience in Regulatory affairs
and activities related to regulatory operations, registration/ approval strategy, stakeholder management and relationship building in the
field of New Drug Approvals, Import and registration of pharmaceutical products, Medical Devices and Cosmetics, Post approval
obligations including Pharmacovigilance across different therapeutic areas.

Core Competencies

 Regulatory Strategy Development  Audit and Inspection Management

 Global Project Management  Cross-Functional Collaboration
 Compliance and Business Planning  Regulatory Issue Resolution
 Stakeholder Management  Training and Mentoring

Career Highlights

 B. Braun Medical India Pvt. Ltd Feb’2019-Till Present

 Accredited Consultants Pvt. Ltd. May’2015-Nov’2018

Academic Qualification

 M. Pharma (Pharmacology & Toxicology), SBSPGI, Dehradun Aug’2012-Dec’2014

 B. Pharma, Roorkee college of Pharmacy, Roorkee Aug’2008-May’2012
 Intermediate, STDBV, Ghaziabad Apr’2007- Mar’2008
 High School, STDBV, Ghaziabad Apr’2005- Mar’2006

Technical Skills Sets

 Regulatory Affairs: India MDR 2017, NDCT Rules 2019, D&C Act & Rules, Regulatory operations and liaison activity
pertaining to Import and Registration, Medical Devices, Voluntary registration, Cosmetics, New Drug Applications, New Drug
Permission, Line extensions, query resolutions, follow-ups, approvals, Regulatory Assessment of MDD/ MDR, Technical
Dossier, Global and Local stakeholder engagements, post approval changes & compliance, Tender management, Budgeting, etc.

 Quality Assurance & Control: ISO 13485, ISO 9001:2015, Implementation of quality management system through quality
policy, quality manual, Preparation of SOPs/ WI, Annual product review, artwork review, etc.

 Vigilance (Phamacovigilance & Materiovigilance): Complaint Management, Literature Search Screening, Global SUSARs,
Risk assessment, CAPA, Global Audit, pre and post audit activities, Recall, FSCA, FSN, Trainings.

 BIS: BIS activities, MHD committee for Indian standards for Medical Devices.

Experience

 B. Braun Medical India Pvt. Ltd- Sr. Executive-Regulatory Affairs

 Prioritizing, Planning and monitoring allocated projects/ applications against defined timelines.
 India Product Registration/ Re-registration of Pharma products and Medical Devices.
 Active coordination with CDSCO and C-DAC for ensuring timely approval.
 Responsible for addendum labelling to ensure compliance to D&C and legal metrology act.
 Regulatory assessment of advertisement and promotional materials
  Maintaining marketing authorization from CDSCO
 Mentored PAN India 06 team members through employee engagement
 New business support ensuring that the new registration applications are submitted as per the launch plan shared by business.
 Provide Regulatory support to Biz for Tender submission.
 Maintain trackers/ MIS for all RA and Vigilance activities.
 Active Inter-departmental coordination for complaint management, recall, field safety corrective actions, field safety notice.
 Successfully handled global audits, pre and post audit activities, QMS and CAPA for pharmaceuticals and medical devices.

 Accredited Consultants Pvt. Ltd- Associate- Regulatory Affairs

 Facilitating clients in defining the regulatory strategy for the new registration/import licenses of medical devices, Drugs/New
Drugs/Cosmetics.
 Preparation, compilation, submission, review and approval of regulatory dossiers medical devices/Drugs/Cosmetics/ NOC/
New Drug Approvals (CTD Module) to CDSCO.
 Meeting as per case, meeting with CDSCO officers for Technical Presentation or to resolve queries as per individual case.
 Coordinated with contract manufacturers, CRO’s to support export and new launches.
 Prepared and reviewed post approval labeling & other variations & ensured the compliance of labeling requirements as per
the Indian Drug Authority.
 Coordinated & Liaised with State FDA to get the permission for additional products, Test Licenses on Form 29,
manufacturing license, GMP certificates and other certificates including COPP.
 Perform Pharmacovigilance activities for various clients.
 Prepare and submit PSUR as per the guidelines issued by the NCC-PvPI.
 SOP Preparation & abiding.
 Successfully handled global audits, pre and post audit activities, CAPA for various clients.

Recognition and Rewards

 Special recognition award in Jan’2023 for Regulatory support function

 Spot It award in Nov’2022 for registration of 25,000 products under voluntary registration.
 Outstanding performance award in Apr’2022 for Regulatory support function
 Superhero of the month in June’2021 for successful execution of voluntary registration project.

IT Credentials

 MS Office tools: Word, Excel, PowerPoint, one drive etc.

 Worked on SAP C3, Sharepoint, Trackwise, RA Tool, RIMS, GetRA

Personal Details

Husband’s Name : Dr. Abhishek Agarwal

Date of Birth : 22-01-1991
Language known : English & Hindi
Marital Status : Married
Interest & Hobbies : Listening to Music, Cooking, Gardening, Travelling

Declaration

I certify that above furnished information by me is true to the best of my knowledge and belief.

Place: Ghaziabad, U.P.

Date: 09.08.2022 GAYATRI GARG