Rupal Singhal Email & Phone Number

New Delhi, Delhi, India

As a Regulatory Affairs Associate, I assist Manager QA/RA in upkeep and updation of technical dossier. Providing support for regulatory affairs activities to assist in regulatory submission, registrations, in compliance with applicable medical device regulations per jurisdiction, guidance and standards.• Compiled Quality documents in a format consistent with applicable guidance documents.• Added advantage by assuring appropriate maintenance of technical documents as per ISO … Show more As a Regulatory Affairs Associate, I assist Manager QA/RA in upkeep and updation of technical dossier. Providing support for regulatory affairs activities to assist in regulatory submission, registrations, in compliance with applicable medical device regulations per jurisdiction, guidance and standards.• Compiled Quality documents in a format consistent with applicable guidance documents.• Added advantage by assuring appropriate maintenance of technical documents as per ISO standards / Regulatory guidelines as applicable.• Coordinate for regulatory inputs and participate in findings of non-compliance. Show less

New Delhi, Delhi, India

As a Regulatory Affairs Trainee, I participated in the in all activities relating to documents preparation, Regulatory submission and follow up to obtain approvals/renewals for products and its variations & line extensions.• Maintained and organized regulatory files/ essential documents (electronic and paper) for proper tracking of information.• Built understanding on regulatory requirements in terms of customer requirements, regulatory compliance and… Show more As a Regulatory Affairs Trainee, I participated in the in all activities relating to documents preparation, Regulatory submission and follow up to obtain approvals/renewals for products and its variations & line extensions.• Maintained and organized regulatory files/ essential documents (electronic and paper) for proper tracking of information.• Built understanding on regulatory requirements in terms of customer requirements, regulatory compliance and drafting dossiers• Drafted answers to address queries for medical device applications responses from regulatory agency • Analyzed and scrutinized documents received for Import license / BA/ BE studies Show less

Gurugram, Haryana, India

As a part of Expert Management Team, performed primary as well as secondary market research. Generated leads for expert insights from doctors / other healthcare professionals to provide the ground level knowledge from the different regions around the globe by connecting / reaching them out through various social media platforms (LinkedIn), E-mails. Also, presenting them with token of appreciation for their valuable time and participation in development in the advancement of healthcare industry.

Mba ( Pharmaceutical Management ), Pharmaceuticals , Health , Management And Administration, 7.7 Cgpa

B.Pharmacy, Pharmacy, 6.9 Cgpa