Name: AMENA FIRDOUS

Phone No: (***)***- ****

Email: ad1tag@r.postjobfree.com

Location: Chicago, IL

US Citizen

Professional Summary

4+ years of global regulatory affairs experience in the pharmaceutical and medical devices industry, focusing on developing regulatory strategies for US, EU, and global submissions to gain market approvals for medical devices worldwide.

Expertise in FDA compliance, authoring submissions, and maintaining up-to-date knowledge of regulatory requirements.

Skilled in assembling documentation for domestic and international regulatory authorities.

Strong leadership and project management skills, demonstrated by effectively supporting 510(k) submissions for medical implants to the FDA, as well as handling responses to FDA letters, supplement requests, and amendments.

Proficient in creating label-specific requirements and master content documents in accordance with country-specific regulations.

Experience in updating SOPs, validation documents, post-approval changes, and qualification reports.

Exceptional scientific and technical skills in regulatory affairs, project management, and quality assurance compliance.

Proven ability to work effectively in multicultural environments, coordinate teams, and provide leadership.

Actively involved in drafting, assembling, and supporting the filing of documentation and submission materials for new and existing products with domestic and international regulatory authorities.

Assisted in technical file preparation to meet EU-MDR requirements.

Participated in cross-functional meetings to provide regulatory guidance and lead cross-functional teams in addressing gaps.

Ensured all legal documents such as COAs and POAs, as well as technical documents, where available and notarized when assembling registration and product launch documents.

Provided support for international product registrations, including the successful launch in Korea by compiling required documents like Power of Attorney (POA), Legal Manufacturer Certificate, and Declaration of Conformity (DoC).

Efficiently managed regulatory paperwork for clinical studies, including protocol processing.

Familiarity with FDA guidelines, extensive experience with submissions to EMEA and Health Canada, including electronic submissions.

Proficient in reviewing submission documents including BER, DoC, GSPRs, TDS, ST, CER, CEP, SSCPs and other essential documents for Class III, IIa and Class IIb medical products.

Successfully led submissions for various product classes, including Class III, IIa, and IIb, demonstrating versatility and regulatory expertise.

Consistently applied critical thinking skills to navigate complex regulatory challenges, ensuring compliance in day-to-day activities.

Collaborated with management to propose innovative solutions and ideas for streamlining complex processes, driving continuous process improvements.

Meticulously reviewed and managed DHF scope lists and archival memos, contributing to robust document control and regulatory compliance.

REGULATORY EXPERIENCE

Client: Medtronics January 2022 – SEP 2023

Role: Regulatory Affairs Specialist

Work location: Remote, Contract

My work is to draft, assemble and support the filings of documentation and submission materials(GSPR, Doc, TDS, ST) for new and existing products to domestic and

international regulatory authorities.

I assist technical files as per EU-MDR requirements.

I attend the cross functional meetings to provide regulatory guidance and to support and represents as lead to the cross functional team tasked to fill gaps.

I constantly take meeting minutes during the meetings with cross functional teams where I used to gather everyone’s task and compile a document and send it to the team via email.

Responsible for developing regulatory strategy, preparing US, EU and Global submissions and obtaining approval to introduce medical device implant to market worldwide.

Authoring and reviewing global submission deliverable for product medical device submission.

I have reviewed submission documents such as DoCs, GSPRs, TDS, ST, CERs, CEPs and other documents for Class III, IIa and Class IIb products.

Worked on doing submissions for Classes such as Class III, IIa and IIb.

Continue to utilize critical thinking skills on day to day activities.

Assist management with innovative solutions/ideas to complex processes driving process improvements.

Reviewed DHF scope lists and archival memos

Work with international customer to develop registration package base on CE mark and other international requirements.

Carried out all assignments to the standards of efficiency, innovation, accuracy, and safety in accordance with company and regulatory requirements.

Get familiar with other databases and apps for the submission purposes.

For Labeling purposes I have reviewed the excel spreadsheet with that of the label where I used to verify whether there is CE marking present on the spreadsheet.

Make sure there is Notified number, UDI-DI, MD symbol on the label.

Maintained up-to-date knowledge of FDA standard and data requirements for different submission.

Effectively support 510(k) submissions for medical implants to the FDA, as well as responses to FDA letters, supplement request and amendments.

Proficient in ISO 13485 quality management system, ensuring regulatory compliance and product quality.

Expertise in medical device design control practices, including the development and maintenance of design controls, risk assessments, and safety assurance.

Skilled in creating and managing comprehensive Design History Files (DHF) documentation, capturing all design and development activities.

Client: Sanofi Jan-2020 - Dec-2021

Role: Global Regulatory Affairs Associate

Location: Remote, Contract

Maintained up-to-date knowledge of FDA standards and data requirements for different submission.

Carried out all assignment to the standards of efficiency, Innovation, accuracy, and safety in accordance with company and regulatory requirement.

I am responsible for the development and implementation of global regulatory strategies obtaining and maintaining authorization for licensing and support for currently registered global and expansion of product into new market.

Assist in the regulatory review of labels, labeling, advertising and promotional materials.

My work is to draft, assemble and support the filing of documentation and submission material for new and existing product to domestic and international regulatory authorities.

Assist in SOP development and review.

Generated XML backbone for electronic submissions. Client: Dr. Reddy’s laboratories DEC 2018 – NOV 2019 Role: Global Regulatory affairs associate

Location: Remote, Contract

Accurately proofread labeling materials including vial/tray labels/cartons/package inserts, etc.

Create proposed labeling, with the input from medical affairs and vigilance, product development, package engineering, and/or marketing; making changes where appropriate.

Coordinated proofreading activities of labeling artwork.

Perform review of draft and final labeling for compliance with USP and FDA requirements.

Responsible for maintaining a high quality and an error-free environment with respect to all labeling components and documentation.

Continue to utilize critical thinking skills on a day to day basis.

Compile detailed documentation for all labeling internal routing i.e., quality documentation change notice (DCN).

Distribution of labeling materials to manufacturing plants, US and international.

Distribution of labeling materials to suppliers/vendors, locally and nationally.

Create labeling in structured product labeling (SPL for XML) format using specialized software for FDA submission.

Maintain electronic labeling files for current/proposed components.

Updated databases for variety of projects.

Assessed management with innovative solutions to complex processes driving process improvements.

Create, review ANDA and stability protocols and nonconformance paperwork in controlled documentation system.

Write work instruction release SOPs, and create forms to establish quality documentation.

Work with cross-functional teams to implement and maintain consistent branding across collateral.

Assessed change controls and prepared submission for ANDA from the change control process.

EDUCATION:

Bachelor of computer science - 2006 Osmania University, Hyderabad India

COMPUTER SKILLS / OTHERS

MS-OFFICE, Adobe Acrobat, Adobe pro, Compliance wire tool, ISI toolbox, SharePoint, Vault, and Microsoft outlook, Windchill/RIMS, Thingworx tool SAP, WOW.

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