Nakia V.

About Nakia V.

Experienced Regulatory Affairs Professional with 6+ years experience in Regulatory and 8+ years in biotech industry, with a focus on rare and autoimmune diseases. I specialize in U.S. and global regulatory strategy, including INDs, BLAs, agency interactions, lifecycle management and post marketing activities. I\'ve served as FDA point of contact for gene therapy programs, supported global approvals (U.S, Japan, Canada), and collaborated cross-functionally to deliver high-quality submissions through systems like Veeva RIM and PromoMat.Known for translating complex science into clear regulatory pathways, I bring a strategic mindset, attention to detail, and a commitment to regulatory excellence. Currently pursuing RAC (U.S.) certification to expand my impact in advancing innovative therapies.Let\'s connect if you\'re passionate about regulatory science, collaboration, and making a difference in patient lives.

Experience

1. Regulatory Affairs Professional-strategy

   Spark Therapeutics, Inc

   Dec 2018 — Present · Philadelphia, PA, US

   Drive results for Regulatory Affairs, supporting Head of Department and other departmental staff in daily operations for the completion of all documentation and activities related to the transmission of technical information in eCTD format, regulatory submissions, and applications to regulatory authorities, including FDA, EMA, Health Canada, and WHO. Research for drug approvals and new product development related to multiple therapeutic areas, including central nervous system, ophthalmology, and liver. Manage CMC correspondence and submissions to FDA (CBER) and Office of Compliance and Biologics Quality (OCBQ). Schedule in-person meetings and teleconferences with EMA and FDA.• Completed application for Registry number with CAS, a division of American Chemical Society that provides products and services for scientific discoveries.• Prepare eCTD submissions to the FDA.• Completed World Health Organization application for SPK-3006 non-proprietary name and managed responses to the WHO INN organization.• Collaborated with Regulatory Affairs Leader on researching information pertaining to Health Canada responses.• Manage and support kick-off meetings, while ensuring deadlines are met, for submission, related to Orphan Drug, DSUR, PBRER, LTFU and PASS Protocol Amendments.• Liaise between cross-functional teams, SMEs, and regulatory strategy/operation leads to ensure high-quality, deliverables and effective communication.

Education

• Rosemont College

  Master of Business Administration (MBA)

  2014 — 2016

• Rosemont College

  Master of Business Administration (M.B.A.)

  2013 — 2016