Sapana Amin-Patel
Gaithersburg,MD
Summary
Regulatory Affairs Consultant with extensive expertise in regulatory compliance and policy development. Proven track record in product approval submissions and post-market surveillance, ensuring adherence to diverse regulations. Strong skills in strategic planning and risk assessment, facilitating effective communication with federal agencies and stakeholders. Achievements include optimizing processes for expedited product approvals and improving organizational comprehension of regulatory complexities.
Overview
17
17
years of professional experience
Work History
FULL-TIME PARENTING & COMMUNITY ENGAGEMENT
Montgomery County
Gaithersburg, USA
12.2024 - Current
- Engaged in meaningful volunteer work with mission-driven organizations while on a professional break, contributing to community resilience, equity, and care.
- Community Bridges (Silver Spring, MD): Mentored girls from under-resourced communities, focusing on leadership, academic success, and civic engagement.
- Upcounty Hub (Montgomery County, MD): Assisted with weekly food and essential goods distribution while upholding privacy and dignity by eliminating documentation barriers.
- Region V Emergency Preparedness Coalition: Participated in an annual hospital-based emergency preparedness exercise supporting regional healthcare and emergency readiness.
- So What Else (Rockville, MD): Supported community relief efforts by organizing donations, conducting inventory, preparing grocery bags, and aiding in vehicle loading/unloading.
- Rebuilding Together (Montgomery County, MD): Provided critical home repairs to help low-income residents stay safely in their homes, contributing to community housing stability.
Senior Regulatory Affairs Specialist (Contract)
ANGIODYNAMICS
, Remote
05.2024 - 09.2024
- Provided global regulatory strategy and submission support for medical devices addressing cardiovascular and oncologic diseases.
- Ensured compliance with international regulatory standards and collaborated cross-functionally to support product lifecycle and market access.
Senior Regulatory Affairs Specialist
QUIDEL ORTHO
Raritan, USA
10.2022 - 12.2023
- Represented regulatory affairs on project teams for new product development of in-vitro diagnostics.
- Compiled global registration tech files.
- Managed product approval licenses with submitting renewals, gap assessments, and updated registration documents.
- Strategic lead for regulatory input to regional teams and regulatory agencies across Asia Pacific, Latin America, and Europe.
- Supported MDSAP audits.
- Configured and deployed document management processes and tools related to global regulatory submissions.
- Implemented and established new regulatory processes for the creation and deployment of regulatory registration packages for international registrations.
Senior Regulatory Affairs Specialist
ZIMMER BIOMET
, Remote
05.2021 - 10.2022
- Authored tech files for global regulatory submissions (APAC, LATAM, EU) for thoracic product portfolio.
- Managed team of contractors hired to support regulatory projects as required.
- Developed regulatory strategies for compliance with global regulations.
- Communicated with regulatory and governmental agencies directly to successfully obtain product licenses.
- Provided regulatory input for post marketing compliance of products.
Senior Regulatory Affairs International Specialist
PHILIPS HEALTHCARE
, Remote
11.2020 - 05.2021
- Configured and deployed document management processes and tools related to global regulatory submissions for image guided therapies.
- Compiled regulatory filings for EU MDR and rolled them out worldwide.
- Recognized as a key talent in the implementation of the European Medical Device Regulation 2017/745 in a medical device multinational.
- Established procedures to identify and implement new ways of working across sites and geographies.
- Considered a key regulatory contact person enabling the regulatory compliance in internationally.
- Prepared product registration files in international markets with local representatives, including follow-up to ensure local approvals and shipping authorization.
- Expanded regulatory knowledge to optimize international regulatory submissions and ability to identify risks within regulatory strategies, while clearly communicating those risks to project teams and senior management.
- Assisted regulatory affairs team with training and recruitment efforts.
Regulatory Affairs Technical Specialist
SIEMENS HEALTHINEERS
Tarrytown, USA
06.2018 - 11.2020
- Developed technical dossiers for Atellica and Advia Centaur products, including new in-vitro diagnostics.
- Completed Device Master Files (DMF) for iVDs to successfully meet new regulatory requirements in India for over 230 assays.
- Worked with international RA team and Siemens Regional Units on project teams to provide regulatory input on development and post-marketing activities.
- Developed a central repository for regulatory documents and trained cross functional teams on SOPs.
- Interacted with health authorities globally to expedite submission process.
Senior Regulatory Affairs Specialist
L BRANDS
New York, USA
01.2017 - 01.2018
- Reviewed raw materials for international market compliance in PLM.
- Reviewed formula compliance for international markets acceptability and issue ingredient list for cosmetics and OTC drugs.
- Researched and analyzed regulations while providing risk-based recommendations internally to marketing, product development, research and development, and creative personnel.
- Provided comprehensive feedback on all product labeling and promotional materials to ensure regulatory compliance and substantiation of claims was provided across international markets.
- Performed industry benchmarking and competitive product analysis research.
- Performed analysis and provided research/advice on inventory management and change management.
- Led the PINK facemasks product launches by working with R&D, suppliers, and legal.
Regulatory Affairs Consultant
LIFECELL CORP
Bridgewater, USA
06.2015 - 05.2016
- Completed international submissions in support of Acelity's Regenerative Medicine Revolve and Strattera products' global regulatory strategy (covering East Asia and Latin America).
- Reviewed promotional/advertising material, while participating in peer review committee meetings.
- Presented global regulatory strategy to senior leadership for new regulatory requirements in regenerative medicine.
- Authored submissions for product registrations in international areas.
- Responded to questions from various health authorities regarding new submissions and existing product registrations related to regulatory/supervisory activities.
- Developed and maintained knowledge of regulations in various countries and regions in order to assess (1) the consequences of regulatory changes for the product and (2) the regulatory consequences of changes in the manufacturing, materials, or marketing of the product.
- Obtained and maintained knowledge of international regulations, regulatory processes, and application of regulations to assigned products while expanding regulatory expertise through relevant training, research papers, and project work.
- Prepared foreign product registration dossiers, including, procurement, and dissemination of technically-oriented documentation (i.e., quantitative/qualitative formulations, ingredient information, product testing, etc.).
- Successfully completed consulting role by obtaining product approvals in Australia, Brazil, Costa Rica, Mexico, Singapore, and South Korea for product portfolio in scope.
Lead Regulatory Affairs Strategist
RECKITT BENCKISER LLC
Parsippany, USA
09.2012 - 11.2014
- Primary regulatory contact for consumer brands (Clearasil, Veet, and Durex), including project management and related cross functional teamwork.
- Successfully obtained the first 510(k) clearance for Reckitt Benckiser LLC under the Durex brand.
- Provided strategic input into development of timeline and registrations related to regulatory and supervisory activities.
- Managed all regulatory activities across new and existing product lines, including 510(k) filings for medical devices and registration listings for imports and FDA medical devices.
- Reviewed and approved promotional advertising for cosmetics and device products.
- Educated cross functional teams on medical device FDA regulations, while acting as subject matter expert at company training and industry conferences.
- Lead American Standard for Testing Methods (ASTM) Committee to propose revisions to current standards.
- Provided regulatory leadership on the Cosmetic Safety Amendment of 2012 (HR4395), which was introduced to improve federal regulation of cosmetics; efforts included making voluntary cosmetic reporting mandatory, creating a new FDA program to review ingredients, creating a new process to set safety levels for trace contaminants, and establishing FDA oversight of the cosmetic ingredient expert panel findings.
- Prepared and communicated this pending legislation to Global Regulatory, as well as other impacted departments, while representing RB at trade organization meetings related to Amendment.
Regulatory Affairs Specialist
AERAS
Rockville, USA
07.2011 - 06.2012
- Company Overview: Global nonprofit biotech working to advance R&D efforts in the development of tuberculosis vaccines
- Managed process of submitting regulatory documents to appropriate global regulatory organizations/authorities in collaboration with pharmaceutical and biotech partners, including BLAs, INDs and CTAs.
- Reviewed new regulatory guidelines and policies, while evaluating their potential impact on open projects and informed related departments regarding applicability and impact.
- Organized cross functional preparation of annual reports for Investigational New Drugs (IND) and Orphan Drugs, including content and timelines.
- Represented Regulatory Affairs on various project and preclinical teams to identify comprehensive global regulatory strategy for access in multiple target countries (Kenya, South Africa, Mozambique, Uganda, India, China), while achieving national regulatory approval for use in human clinical trials.
- Served as relationship liaison between Aeras and external partners (i.e., industry peers and regulatory government agencies) to progress forward with broader R&D efforts, while providing regulatory intelligence to both internal and external parties.
- Authored IND Annual Reports for FDA, and Standard Operating Procedures for ClinicalTrials.gov.
- Global nonprofit biotech working to advance R&D efforts in the development of tuberculosis vaccines
Regulatory/Quality Specialist
ALCAVIS INTERNATIONAL, INC.
Frederick, USA
08.2010 - 07.2011
- Reviewed and approved changes to controlled EPA and FDA labeling, while maintaining supporting documentation.
- Led efforts for regulatory submissions and audits; including worked with regulatory agencies and contractors to determine documentation requirements, while interpreting appropriate laws and regulations as required to ensure compliance.
- Conducted facility-oriented quality investigations and reviewed/proposed corrective actions in accordance with GMP standards, while performing change impact assessments and managing related project timelines.
- Performed raw material/finished product receiving inspection.
- Reviewed attribution inspection, datasheets, log sheets, technical reports, deviation reports, and standard operating procedures as needed.
- Prepared batch records for issuance, performed production line clearance review, and reported resulting data/analytics.
- Successfully submitted a 510k for the Alcavis Wound Cleanser - Class II Medical Device.
Regulatory Affairs Health Solutions Contractor
SCIENCE APPLICATIONS INTERNATIONAL CORPORATION (SAIC) - NIH NIAID
Frederick, USA
02.2009 - 08.2010
- Project management responsibilities included: IND life-cycle management, oversight of contract deliverables, critical process oversight and improvement, and edit/review of contractual statements of work.
- Reviewed and analyzed preclinical, clinical, and technical data for compliance with requirements of relevant regulatory authorities; while writing technical reports, product stability summaries, standard operating procedures/manuals, and regulatory documents for INDs.
- Played an integral in the development of, and revision process for, all related documents.
- Submissions included, but are not limited to: INDs, Non-Disclosure Agreements (NDA), Biologics License Applications (BLA), information and protocol amendments, clinical study reports, and responses to the FDA.
- Developed and implemented TrackWise system/notifications for regulatory, safety, and clinical trials management users, while providing onsite customer support for quality interaction with clients and agency.
- Provided regulatory support to scientists at National Institutes of Health (NIH), Division of Infectious Diseases for Vaccine and Biolog.
Protocol Information Specialist
TECHNICAL RESOURCES INTERNATIONAL - NCI
Bethesda, USA
05.2008 - 02.2009
- Completed regulatory submissions under CTEP.
- Advised clinical sites to follow compliance/regulatory measures in reference to IND submissions, while implementing effective communication methods between pharmaceutical branch and regulatory branch regarding IND submissions and various other regulatory guidelines.
- Coordinated activities for protocol review with principal investigators, institutional review board, and research site.
- Worked with institutional review boards in maintaining relevant and up to date data to follow compliance of regulatory guidelines.
- Abstracted scientifically pertinent data into the CTEP enterprise database from protocols.
- Verified key elements of protocols submitted under an IND comply with regulation 21 CFR 50.24.
- Processed and maintained protocol amendments/revisions while coordinating with staff in six various branches within the National Cancer Institute (both investigational and approved oncology drug products).
- Organized weekly peer review committee meetings with various branches per discussion of implementation of new clinical study trials, both domestic and international.
Education
Graduate Certificate - Human Resources Management
CORNELL UNIVERSITY
New York, NY05.2019
MS - Regulatory Affairs, Drugs, Biologics & Medical Devices
NORTHEASTERN UNIVERSITY
Boston, MA09.2017
BS - Health Science
PHILADELPHIA COLLEGE OF PHARMACY
Philadelphia, PA05.2008
Skills
- Microsoft Office Suite (PowerPoint, Word, Excel)
- SharePoint
- Electronic Common Technical Document (ECTD)
- Document Management Systems (Documentum)
- TrackWise
- HSROAD
- Starting Point
- SAP Product Lifecycle Management (PLM)
- OTIS
- Regulatory Desk (RegDesk)
- Regulatory Information Management System (RIMS)
- Veeva Vault
- Regulatory compliance
- Global submissions
Affiliations And Skills
MS Office (PowerPoint, Word, Excel), Sharepoint, eCTD, Documentum, TrackWise, HSROAD, Starting Point, SAP (PLM), OTIS, RegDesk, RIMS, GMP Training, GLP Training, NIH Award for Outstanding Work for H1N1 Vaccine, GCP Training, EU MDR, IVDR Training, Risk Management Training, Volunteered for Boys and Girls for Careers in STEM (2011), Participated as Active Member in Diversity and Inclusion Groups
Timeline
FULL-TIME PARENTING & COMMUNITY ENGAGEMENT
Montgomery County
12.2024 - Current
Senior Regulatory Affairs Specialist (Contract)
ANGIODYNAMICS
05.2024 - 09.2024
Senior Regulatory Affairs Specialist
QUIDEL ORTHO
10.2022 - 12.2023
Senior Regulatory Affairs Specialist
ZIMMER BIOMET
05.2021 - 10.2022
Senior Regulatory Affairs International Specialist
PHILIPS HEALTHCARE
11.2020 - 05.2021
Regulatory Affairs Technical Specialist
SIEMENS HEALTHINEERS
06.2018 - 11.2020
Senior Regulatory Affairs Specialist
L BRANDS
01.2017 - 01.2018
Regulatory Affairs Consultant
LIFECELL CORP
06.2015 - 05.2016
Lead Regulatory Affairs Strategist
RECKITT BENCKISER LLC
09.2012 - 11.2014
Regulatory Affairs Specialist
AERAS
07.2011 - 06.2012
Regulatory/Quality Specialist
ALCAVIS INTERNATIONAL, INC.
08.2010 - 07.2011
Regulatory Affairs Health Solutions Contractor
SCIENCE APPLICATIONS INTERNATIONAL CORPORATION (SAIC) - NIH NIAID
02.2009 - 08.2010
Protocol Information Specialist
TECHNICAL RESOURCES INTERNATIONAL - NCI
05.2008 - 02.2009
Graduate Certificate - Human Resources Management
CORNELL UNIVERSITY
MS - Regulatory Affairs, Drugs, Biologics & Medical Devices
NORTHEASTERN UNIVERSITY
BS - Health Science
PHILADELPHIA COLLEGE OF PHARMACY
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