Amana Mahamoon
Boston,MA
Summary
Dynamic and results-oriented healthcare professional with over six years of experience in pharmacy operations, patient outreach, and healthcare management. Proven track record in regulatory affairs, with specialized expertise in IND and BLA submissions, supported by advanced analytical and data management skills. A collaborative leader skilled in driving cross-functional teams and navigating complex projects to achieve exceptional results in clinical development. Committed to enhancing patient care and optimizing healthcare initiatives through innovative problem-solving and effective communication. Eager to leverage my skills and passion for regulatory excellence to contribute to the advancement of the pharmaceutical industry and improve patient outcomes.
Overview
6
6
years of professional experience
1
1
Certification
Work History
REGULATORY AFFAIRS SPECIALIST
Taysha Gene Therapies
10.2023 - Current
- Spearheaded preparation and submission of regulatory documents for the REVEAL Adolescent and Pediatric Gene Therapy Trials, ensuring compliance with FDA, MHRA, and Health Canada requirements.
- Managed the IND and MHRA/EU application process, drafting and submitting protocol amendments and safety reports, while maintaining timely regulatory correspondence to meet study timelines.
- Consolidated global regulatory intelligence on Rett Syndrome gene therapy treatments, monitoring worldwide submissions and approval statuses to support strategic planning and ensure alignment with evolving international regulatory landscapes.
- Collaborated with clinical teams to develop and refine TSHA-102 clinical trial protocols, focusing on safety and efficacy endpoints in Rett syndrome.
- Implemented a regulatory document tracking system using Smartsheet, reducing documentation turnaround times by 25% through enhanced visibility and accountability.
- Designed and maintained a regulatory dashboard, providing real-time updates on submission statuses, project timelines, and compliance metrics.
- Reviewed and finalized regulatory submission documents, including protocols, informed consent forms and clinical study reports, ensuring accuracy post-publishing.
- Planned and developed detailed timelines and resource allocation for future BLA submissions to align with corporate strategies for product launches.
- Conducted training sessions and developed materials to educate internal teams on regulatory requirements and clinical trial documentation best practices.
- Prepared timely responses to FDA queries on trial design and data interpretation, ensuring continued regulatory approvals.
- Led the planning, preparation, and coordination of FDA Type B and Type D meetings, including drafting detailed meeting outlines, consolidating questions, and preparing briefing materials; conducted a Scientific Advice meeting with the MHRA (UK), consolidating all correspondence and agency feedback to streamline future submissions and regulatory strategies.
- Engaged with external regulatory consultants to navigate complex regulatory requirements across North America, Europe, and Canada, ensuring adherence to varying international regulations.
- Mentored junior regulatory staff on submission processes and regulatory documentation standards.
- Led initiatives to improve regulatory document review processes, reducing average review times from 10 days to 5 days.
- Independently managed the USAN submission process, leading to the successful naming approval for TSHA-102 and developing a plan for brand name submission post-BLA.
- Managed RAID log to track regulatory risks, actions, issues, and decisions, providing senior management with mitigation strategies for potential product development challenges.
- Published electronic submissions in eCTD and non-eCTD formats for FDA, EMA, and other regulatory agencies, including formatting, internal hyperlinking, bookmarks, and sequence-level publishing.
- Gained expertise in reviewing, interpreting, and applying regulatory Guidance's from CFR Title 21 and ICH guidelines for US, Canada, and other international markets.
- Performed and documented quality control checks to maintain compliance with company initiatives.
MEDICAL INFORMATION SPECIALIST (CONTRACT)
Sarfez Pharmaceutical, Inc
05.2023 - 10.2023
- Successfully promoted SOAANZ, a novel formulation of torsemide, to cardiologists, nephrologists, and other healthcare professionals, effectively communicating its unique benefits in treating heart failure.
- Effectively managed and covered the New England territory (MA, CT, NH, RI), conducting an average of 100 site visits per week, resulting in meaningful interactions with prescribers and driving physician scripts.
- Served as a subject matter expert on specific therapeutic areas, offering guidance and insight when required by team members or external parties.
- Ensured full compliance with all industry and government regulations governing the promotion and sale of pharmaceuticals.
- Cultivated strong and lasting relationships with healthcare providers, including physicians, nurse practitioners, and physician assistants.
- Developed and maintained comprehensive medical information content, including FAQs, standard response letters, and product monographs.
- Conducted thorough literature searches and reviewed scientific publications to support medical information activities, staying current with the latest medical research and advancements.
- Provided training sessions for new hires, enhancing their understanding of departmental workflows and best practices.
PHARMACIST (GRADUATE)
CVS Pharmacy
10.2021 - 08.2023
- Supervised and trained four pharmacy technicians, two interns, and fellow pharmacist trainees; provided performance feedback; ensured patient safety by following pharmaceutical and regulatory guidelines.
- Collaborated with team members on purchasing, ordering, and receiving inventory for controlled substances (Schedule III-V); oversaw the ordering of Schedule II substances using DEA Form 222, ensuring compliance and accuracy in documentation.
- Helped develop and oversee a training protocol for the New Care Plus workflow, which improved efficacy by 52% and reduced prescription processing time from 6 minutes to 2.3 minutes.
- Assisted in the development of five key policies and procedures for pharmacy operations, which resulted in a 15% improvement in audit performance and a 20% reduction in operational errors related to controlled substance handling.
- Stayed current with evolving retail pharmacy regulations and standards, providing regular updates to cross-functional teams.
- Researched medical information and provided evidence-based advice to healthcare staff members to improve current medical protocols regarding patient care.
- Counseled patients on medication adherence, side effects, and potential drug interactions, resulting in improved patient understanding and compliance.
- Increased team efficiency by 20% by implementing performance metrics and conducting regular feedback sessions.
- Utilized pharmacy management software RX30 for inventory management and patient care documentation.
- Expanded pharmacy services by overseeing the successful launch of immunization programs and medication therapy management initiatives.
- Participated in immunization initiatives, administering over 1500 vaccines during the campaign period and achieving a 95% patient satisfaction rate through education on health and wellness.
CLINICAL PHARMACY FIELD ASSOCIATE - REGULATORY AFFAIRS
Boston Area Hospitals and Clinics and MCPHS
09.2019 - 05.2021
- Utilized expertise in IND preparation, regulatory publishing, and FDA guidelines to ensure timely and accurate submission of regulatory documents in compliance with standards.
- Actively collaborated in the preparation and submission of regulatory documents, including IND and CTA applications, contributing to successful regulatory approvals.
- Monitored drug therapy and adjusted doses, using tools such as ADR monitoring, TDM software, medication reconciliation, and CDSS to optimize patient care for conditions like hypertension, diabetes, and infectious diseases.
- Stayed updated with current research and regulatory guidelines from the FDA, EMEA, and ICH, providing evidence-based recommendations that improved patient health outcomes.
- Created and maintained comprehensive technical documentation, including Device Master Files (DMFs) and Design History Files (DHFs), ensuring compliance with industry standards.
- Led the review and preparation of clinical study reports and protocols to ensure regulatory compliance and consistency with best practices.
- Developed and maintained medication utilization dashboards and data visualization tools (e.g., Tableau, Power BI, QlikView) to monitor trends in medication usage, leading to data-driven decision-making.
- Developed standard operating procedures (SOPs) for regulatory submission processes, improving consistency and efficiency across teams.
- Collaborated effectively with cross-functional teams, including scientists, engineers, quality assurance, and regulatory affairs professionals, to align product development with regulatory requirements.
- Conducted literature reviews using PubMed, Cochrane Library, and Embase; presented findings and recommendations to the pharmacy and therapeutics committee and other stakeholders.
- Participated in training and mentoring junior staff on regulatory processes and compliance standards, enhancing team competency and efficiency by 80%.
- Engaged in risk assessment activities to identify potential regulatory compliance issues, proactively addressing concerns to minimize delays in submission approvals.
- Coordinated with external partners and stakeholders to gather necessary documentation and data for regulatory submissions, ensuring alignment with submission requirements.
- Liaised with global partners on shared initiatives, fostering a cohesive approach towards medical information management across regions.
PHARMACY INTERN
Walgreens Pharmacy
02.2021 - 09.2021
- Interfaced with patients and provided instructions and advice on medication adherence under the supervision of registered pharmacists.
- Scrutinized insurance claims and liaised with clients and insurance companies to resolve rejections and billing issues.
- Utilized in-depth knowledge of pharmacy computer programs to access prescription information such as patient and prescribed data, drug dosage, and insurance billing.
QUALITY ASSURANCE ASSOCIATE
ProCare LTC
09.2020 - 01.2021
- Supported the Quality Management System (QMS) to ensure compliance with federal and state regulations, contributing to a culture of quality and safety.
- Reviewed and released manufacturing and testing documentation, including batch records, deviations, and CAPAs, ensuring timely and accurate compliance.
- Conducted compliance investigations by reviewing executed batch records, resolving documentation issues, and achieving a 20% reduction in discrepancies over three months.
- Engaged in root cause analysis of GxP non-compliances and customer product quality complaints, leading to updated training for pharmacy staff and improved processes.
- Contributed to the development and implementation of corrective and preventive action plans, successfully improving process compliance by 15%.
- Assisted in the preparation and submission of quality metrics and regulatory documentation, ensuring adherence to industry standards and enhancing operational efficiency.
- Conducted Product Quality Reviews (PQRs) to assess product performance, identifying and resolving critical quality issues that improved customer satisfaction scores.
- Provided training and support to team members on quality processes and documentation standards, enhancing team efficiency by 25%.
- Participated in internal GxP audits and follow-up actions, ensuring 100% closure of observations within required timelines and fostering continuous improvement.
- Utilized quality tools and techniques to document investigations and drive initiatives, implementing a new electronic documentation system that reduced processing time by 30%.
- Demonstrated exceptional attention to detail and strong project and time management skills by successfully managing multiple high-priority tasks simultaneously meeting deadlines and ensuring accuracy.
CUSTOMER CARE REPRESENTATIVE
MCPHS Pharmacy Outreach Program
10.2018 - 03.2019
- Shepherded Massachusetts Medicare-covered patients through the health plan selection process, emphasizing medication and prescription drug coverage to meet clients' needs.
- Delivered Medication Therapy Management services to both patients and healthcare professionals.
- Built rapport with customers through active listening and empathetic responses, fostering positive relationships.
Education
Master of Business Administration (M.B.A.) in Healthcare Management -
Massachusetts College of Pharmacy And Health Science (MCPHS University)
Boston05.2024
Doctor of Pharmacy (Pharm.D.) -
Massachusetts College of Pharmacy And Health Science (MCPHS University)
Worcester05.2021
Skills
- Regulatory Compliance & Strategy
- Dossier Submission & Management
- Technical Writing & Documentation
- Medical Information Expertise
- Cross-Functional Collaboration
- Business & Technology Acumen
- Analytical & Critical Thinking
- Strategic Regulatory Planning
- Project Management
- Regulatory Affairs Management
- Effective Communication
- Adaptability & Resilience
- Attention to Detail
- Global Regulatory Affairs
Certification
- Regulatory Affairs Certification (RAC) | Regulatory Affairs Professionals Society (RAPS) | Expected August 2025
- Regulatory Affairs Training Certificate | Duke University School of Medicine | Issued May 2023
- PowerMBA Certificate | PowerMBA | Issued March 2021
- NAPLEX and MPJE Massachusetts Law Exam | Board of Pharmacy
- Essentials of Project Management Course | LinkedIn Learning
- BLS/CPR Certification & OSHA/Bloodborne Pathogens Certification | American Heart Association
- APhA Medication Therapy Management (MTM) Certificate | APhA Foundation
- APhA Immunization Delivery Certificate | APhA Foundation
- HIPAA Certification | Expires May 2025
Affiliations
- Association of Clinical Research Professionals (ACRP)
- Regulatory Affairs Professionals Society (RAPS)
- American Pharmacists Association (APhA)
- Academy of Managed Care Pharmacy (AMCP)
Awards and Honors
- Dean’s List | Recognized for academic excellence during the following terms: Fall 2017, Spring 2018, Fall 2019, Spring 2020, Summer 2020, Fall 2023, Spring 2023, Fall 2024
- Dominion Nuclear Connecticut Physical Sciences Award | Finalist – Physical Sciences | CSF Medallion & Acrylic Award for developing a low-cost diabetic test for use in developing countries.
- Barnes Aerospace Applied Technology Award | 1st Place – Applied Technology | Trophy & Medallion for designing a novel water filtration and disinfection system using a salad spinner, dynamo, and high-intensity LEDs for rural applications.
Timeline
REGULATORY AFFAIRS SPECIALIST
Taysha Gene Therapies
10.2023 - Current
MEDICAL INFORMATION SPECIALIST (CONTRACT)
Sarfez Pharmaceutical, Inc
05.2023 - 10.2023
PHARMACIST (GRADUATE)
CVS Pharmacy
10.2021 - 08.2023
PHARMACY INTERN
Walgreens Pharmacy
02.2021 - 09.2021
QUALITY ASSURANCE ASSOCIATE
ProCare LTC
09.2020 - 01.2021
CLINICAL PHARMACY FIELD ASSOCIATE - REGULATORY AFFAIRS
Boston Area Hospitals and Clinics and MCPHS
09.2019 - 05.2021
CUSTOMER CARE REPRESENTATIVE
MCPHS Pharmacy Outreach Program
10.2018 - 03.2019
Master of Business Administration (M.B.A.) in Healthcare Management -
Massachusetts College of Pharmacy And Health Science (MCPHS University)
Doctor of Pharmacy (Pharm.D.) -
Massachusetts College of Pharmacy And Health Science (MCPHS University)
- Regulatory Affairs Certification (RAC) | Regulatory Affairs Professionals Society (RAPS) | Expected August 2025
- Regulatory Affairs Training Certificate | Duke University School of Medicine | Issued May 2023
- PowerMBA Certificate | PowerMBA | Issued March 2021
- NAPLEX and MPJE Massachusetts Law Exam | Board of Pharmacy
- Essentials of Project Management Course | LinkedIn Learning
- BLS/CPR Certification & OSHA/Bloodborne Pathogens Certification | American Heart Association
- APhA Medication Therapy Management (MTM) Certificate | APhA Foundation
- APhA Immunization Delivery Certificate | APhA Foundation
- HIPAA Certification | Expires May 2025
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