Regulatory Affairs Specialist Resume Example

Senior Regulatory Affairs Specialist · Vertex Pharmaceuticals

Boston, MA · 2021 - Present

• Led preparation and submission of 3 Investigational New Drug (IND) applications and 2 New Drug Applications (NDAs) to the FDA, resulting in 100% acceptance rate for initial submissions.
• Managed post-market surveillance and reporting for a portfolio of 5 medical devices, ensuring compliance with FDA 21 CFR Part 806 regulations and reducing audit findings by 25%.
• Collaborated with R&D and Clinical Operations teams to develop regulatory strategies for early-stage pipeline products, accelerating preclinical-to-clinical transition by an average of 3 months.
• Authored and reviewed regulatory sections of clinical study reports and marketing authorization applications (MAAs) for EU markets, contributing to a 90% first-cycle approval rate.

Regulatory Affairs Specialist · Boston Scientific

Marlborough, MA · 2018 - 2021

• Prepared and submitted 8 Premarket Notification (510(k)) applications for Class II medical devices, achieving regulatory clearance for all submissions within an average of 150 days, 20% faster than industry average.
• Coordinated with engineering and quality assurance teams to ensure product design and manufacturing processes met FDA and ISO 13485 standards, improving audit readiness by 30%.
• Reviewed and approved product labeling, promotional materials, and instructions for use (IFUs) for adherence to global regulatory requirements, preventing 12 potential non-compliance issues.
• Supported post-market activities including adverse event reporting and recall management, ensuring timely submission to regulatory authorities and maintaining a clean inspection record.

M.S. in Regulatory Affairs · Northeastern University

Boston, MA · 2018 - 2020

• GPA: 3.9/4.0
• Thesis: 'Impact of Expedited Review Pathways on Oncology Drug Development Timelines'
• Coursework included: Global Regulatory Strategy, FDA Law and Regulation, Clinical Trial Design, Quality Systems for Medical Devices

B.S. in Pharmaceutical Sciences · University of Massachusetts Amherst

Amherst, MA · 2014 - 2018

• Cum Laude graduate
• GPA: 3.7/4.0
• Minor in Biology

Regulatory Affairs Specialist · Baxter International

Deerfield, IL · 2022 - Present

• Managed regulatory submissions for Class II and III medical devices, achieving 100% on-time filing rate for 15+ complex submissions to FDA and EU notified bodies.
• Collaborated with R&D and quality teams to ensure product development aligned with global regulatory requirements, reducing compliance risks by 20%.
• Interpreted and applied new EMEA MDR and IVDR regulations, developing and implementing training for 50+ cross-functional team members.
• Spearheaded the preparation and review of technical documentation for CE marking for three key product lines, facilitating market access in over 15 countries.

Regulatory Affairs Associate · AbbVie

North Chicago, IL · 2020 - 2022

• Supported the preparation and filing of INDs, NDAs, and BLAs, contributing to 5 successful approvals within two years.
• Conducted in-depth regulatory research to assess requirements for product variations and market expansion in APAC and LATAM regions, identifying potential expedited pathways.
• Maintained and updated regulatory databases (e.g., Veeva Vault RIM) with 99% accuracy for over 200 active registrations and licenses.
• Facilitated document control processes for regulatory submissions, ensuring all materials met FDA electronic submission guidelines (eCTD format).

Quality Assurance Analyst · Abbott Laboratories

Abbott Park, IL · 2017 - 2020

• Analyzed quality control data for diagnostic products, identifying trends and recommending process improvements that reduced non-conformances by 15%.
• Developed and implemented standard operating procedures (SOPs) for quality inspections, improving audit readiness scores by 25%.
• Assisted in internal and external audits (FDA, ISO 13485), ensuring compliance and resolving 95% of findings within the specified timeframe.
• Collaborated with manufacturing teams to investigate root causes of quality issues, leading to a 10% reduction in product defects.

Master of Science in Regulatory Compliance · Northwestern University

Evanston, IL · 2019 - 2021

• Completed thesis on expedited regulatory pathways for novel medical devices.
• Maintained a 3.9/4.0 GPA while working full-time.

Bachelor of Science in Biology, Minor in Chemistry · University of Illinois Urbana-Champaign

Urbana, IL · 2013 - 2017

• Graduated with High Honors, Dean's List for 6 semesters.
• Conducted undergraduate research in molecular genetics, contributing to two published papers.