Project Manager - Expanded Access / Named Patient Programmes

• Feb 2023 - Present

Regulatory Affairs Project Manager

• Aug 2019 - Oct 2022

• Planned and managed projects worth $1 million for small/mid sized pharma, biotech, and medical device clients. • Initiated and led BD initiatives for pharmaceutical/biotech accounts, leading to business revenues of $500K. • Executed, managed, and delivered a diverse range of key regulatory projects such as IND and NDA Submissions, CSR Publishing, BLA Submissions, Product registration across difference markets, regulatory intelligence reports, 510k preparation for medical devices and… Show more • Planned and managed projects worth $1 million for small/mid sized pharma, biotech, and medical device clients. • Initiated and led BD initiatives for pharmaceutical/biotech accounts, leading to business revenues of $500K. • Executed, managed, and delivered a diverse range of key regulatory projects such as IND and NDA Submissions, CSR Publishing, BLA Submissions, Product registration across difference markets, regulatory intelligence reports, 510k preparation for medical devices and strategic advisory projects. • Delivered projects under strict timelines and by utilizing effective resources; ensured milestones are met as per timelines. • Monitored project metrics such as quality, costs, client satisfaction and resource utilization; developed status reports and case studies and presented findings to senior client management. • Risk Management – developed issue logs and risk logs for projects, implemented risk responses, and troubleshooting project issues, leading to positive business relationships. • Managed, and built relationships with existing and new client’s to maintain business continuity and revenue growth. Show less • Planned and managed projects worth $1 million for small/mid sized pharma, biotech, and medical device clients. • Initiated and led BD initiatives for pharmaceutical/biotech accounts, leading to business revenues of $500K. • Executed, managed, and delivered a diverse range of key regulatory projects such as IND and NDA Submissions, CSR Publishing, BLA Submissions, Product registration across difference markets, regulatory intelligence reports, 510k preparation for medical devices and… Show more • Planned and managed projects worth $1 million for small/mid sized pharma, biotech, and medical device clients. • Initiated and led BD initiatives for pharmaceutical/biotech accounts, leading to business revenues of $500K. • Executed, managed, and delivered a diverse range of key regulatory projects such as IND and NDA Submissions, CSR Publishing, BLA Submissions, Product registration across difference markets, regulatory intelligence reports, 510k preparation for medical devices and strategic advisory projects. • Delivered projects under strict timelines and by utilizing effective resources; ensured milestones are met as per timelines. • Monitored project metrics such as quality, costs, client satisfaction and resource utilization; developed status reports and case studies and presented findings to senior client management. • Risk Management – developed issue logs and risk logs for projects, implemented risk responses, and troubleshooting project issues, leading to positive business relationships. • Managed, and built relationships with existing and new client’s to maintain business continuity and revenue growth. Show less

Graduate Teaching Assistant, Organic Chemistry Lab

• Sep 2017 - Dec 2018

• Ordered and prepared reagents, chemicals, glassware and kits necessary for performing organic chemistry experiments. • Performed experiments prior to lab sessions to ensure any troubleshooting or changes required in the protocol. • Monitored laboratory inventory by creating and updating records of all supplies and equipment. • Coordinated and collaborated with other teaching assistants to ensure an engaging and safe laboratory environment. • Ordered and prepared reagents, chemicals, glassware and kits necessary for performing organic chemistry experiments. • Performed experiments prior to lab sessions to ensure any troubleshooting or changes required in the protocol. • Monitored laboratory inventory by creating and updating records of all supplies and equipment. • Coordinated and collaborated with other teaching assistants to ensure an engaging and safe laboratory environment.

Regulatory Affairs Intern

• Jun 2018 - Aug 2018

• Assisted in preparation of high-quality dossiers, drug substance and/or drug product quality documentation to support regulatory compliance submissions. • Researched the process of having FDA/EMDA approved pharmaceuticals registered and commercialized in the UAE. • Reviewed, evaluated, and compiled files and reports for eCTD submissions. • Published the dossier using eCTD Publishing Tools and submitted via the UAE Ministry of Health electronic submission gateway. • Assisted in preparation of high-quality dossiers, drug substance and/or drug product quality documentation to support regulatory compliance submissions. • Researched the process of having FDA/EMDA approved pharmaceuticals registered and commercialized in the UAE. • Reviewed, evaluated, and compiled files and reports for eCTD submissions. • Published the dossier using eCTD Publishing Tools and submitted via the UAE Ministry of Health electronic submission gateway.

Biomedical Engineering Intern

• Jan 2016 - Jul 2016

• Performed preventive maintenance for medical devices and prepared safety reports as per protocol. • Assisted biomedical engineers in installation and troubleshooting of biomedical equipment. • Attended user training sessions on the functioning and operation of life saving class 3 medical devices. • Analyzed potential cost-cutting methods in the Biomedical department and Hospital; presented findings to the General Manager. • Studied and presented findings for the academic project… Show more • Performed preventive maintenance for medical devices and prepared safety reports as per protocol. • Assisted biomedical engineers in installation and troubleshooting of biomedical equipment. • Attended user training sessions on the functioning and operation of life saving class 3 medical devices. • Analyzed potential cost-cutting methods in the Biomedical department and Hospital; presented findings to the General Manager. • Studied and presented findings for the academic project, ‘Lifecycle Management of Medical Equipment'. Show less • Performed preventive maintenance for medical devices and prepared safety reports as per protocol. • Assisted biomedical engineers in installation and troubleshooting of biomedical equipment. • Attended user training sessions on the functioning and operation of life saving class 3 medical devices. • Analyzed potential cost-cutting methods in the Biomedical department and Hospital; presented findings to the General Manager. • Studied and presented findings for the academic project… Show more • Performed preventive maintenance for medical devices and prepared safety reports as per protocol. • Assisted biomedical engineers in installation and troubleshooting of biomedical equipment. • Attended user training sessions on the functioning and operation of life saving class 3 medical devices. • Analyzed potential cost-cutting methods in the Biomedical department and Hospital; presented findings to the General Manager. • Studied and presented findings for the academic project, ‘Lifecycle Management of Medical Equipment'. Show less

Summer Intern

• Jul 2015 - Aug 2015

Trained in the basics of nanoparticle synthesis and their characterization by use of techniques such as Dynamic Light Scattering, Zeta Potential Measurement, Ultra Violet-Visible Spectroscopy, Fourier Transform-Infra Red Spectroscopy and X-Ray Diffractometry; Successfully synthesized iron nanoparticles under the mentorship and guidance of faculty. Trained in the basics of nanoparticle synthesis and their characterization by use of techniques such as Dynamic Light Scattering, Zeta Potential Measurement, Ultra Violet-Visible Spectroscopy, Fourier Transform-Infra Red Spectroscopy and X-Ray Diffractometry; Successfully synthesized iron nanoparticles under the mentorship and guidance of faculty.

Quality and Surveillance Auditing Intern

• Jun 2014 - Aug 2014

• Conducted quality audits for Sanbook’s clientele in the Cosmetic, Pharmaceutical and Healthcare sectors as per different standards – ISO 9001(quality), ISO 14001(Environmental), OHSAS 18001(Occupational Health and Safety), ISO 22716(Cosmetics & Perfumes), HACCP • Prepared detailed quality audit reports for clients and helped in granting quality accreditation renewals. • Reviewed the Audit Verification Checklist, document results, and reported to immediate supervisor. • Executed… Show more • Conducted quality audits for Sanbook’s clientele in the Cosmetic, Pharmaceutical and Healthcare sectors as per different standards – ISO 9001(quality), ISO 14001(Environmental), OHSAS 18001(Occupational Health and Safety), ISO 22716(Cosmetics & Perfumes), HACCP • Prepared detailed quality audit reports for clients and helped in granting quality accreditation renewals. • Reviewed the Audit Verification Checklist, document results, and reported to immediate supervisor. • Executed implementation of Quality, Environment and Health & Safety Management System for client companies. • Completed market analysis and drafted reports on potential customers in the Cosmetic, Pharmaceutical and Healthcare sectors in the GCC region. Show less • Conducted quality audits for Sanbook’s clientele in the Cosmetic, Pharmaceutical and Healthcare sectors as per different standards – ISO 9001(quality), ISO 14001(Environmental), OHSAS 18001(Occupational Health and Safety), ISO 22716(Cosmetics & Perfumes), HACCP • Prepared detailed quality audit reports for clients and helped in granting quality accreditation renewals. • Reviewed the Audit Verification Checklist, document results, and reported to immediate supervisor. • Executed… Show more • Conducted quality audits for Sanbook’s clientele in the Cosmetic, Pharmaceutical and Healthcare sectors as per different standards – ISO 9001(quality), ISO 14001(Environmental), OHSAS 18001(Occupational Health and Safety), ISO 22716(Cosmetics & Perfumes), HACCP • Prepared detailed quality audit reports for clients and helped in granting quality accreditation renewals. • Reviewed the Audit Verification Checklist, document results, and reported to immediate supervisor. • Executed implementation of Quality, Environment and Health & Safety Management System for client companies. • Completed market analysis and drafted reports on potential customers in the Cosmetic, Pharmaceutical and Healthcare sectors in the GCC region. Show less