Nakia Vance

About Nakia Vance

Welcome to my profile. I am a detail-oriented regulatory affairs leader with more than six years of experience in the pharmaceutical industry, including four years driving results for project management, submission of regulatory documentation and applications, and tracking of submissions/deadlines related to regulatory approval and new product development. The transition to my current role was a pivotal event that has changed the trajectory of my career future. I am passionate about what I do because I can utilize my excellent interpersonal, customer service, and relationship building skills to ensure the accelerated progress of pharmaceutical product development. With a strong background in human resources, I was already well-versed in ensuring regulatory compliance and interpreting/explaining regulations to employees in easy-to-understand language. Now, I am doing the same thing, but on a much broader, global scale, with an excellent working knowledge of North American and European regulations related to submissions for drug development, ongoing documentation, and regulatory compliance. I have a proven track record of managing communications with global health authorities and coordinating live and online conferences to spur approval for product development and launch. A skilled communicator, I am able to serve as liaison across departments to ensure coordination of efforts and consistent/concise communication between all parties. I have repeatedly demonstrated my competence for resolving issues and can build consensus for forward movement of projects. I am a passionate team player, so I take time to stay abreast of my career growth and success. As a result, I am able to adapt to many environments of cohesion which allows me to stay motivated and mobilize as a team player for achievement of organizational objectives. My key areas of expertise include, but are not limited to, Pharmacy Operations, Strategy Development & Execution, Drug Development & Launch, Customer Service, Communication with Regulatory Authorities, Regulatory Submissions, Database Management, Regulatory Compliance, FDA, EMA, Health Canada, WHO, Event/Meeting Management, Cross-Functional Team Collaboration, Team Building, Coaching, Mentoring, Staff Development, and Leadership. If you would like to discuss my skills and background, you will find my contact information in this profile. Thank you for reading it.

Experience

1. Sr Regulatory Affairs Specialist

   Spark Therapeutics, Inc

   Jun 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), MBA

  2014 — 2016

• Rosemont College

  Master of Business Administration (M.B.A.), Entrepreneurship/Entrepreneurial Studies

  2013 — 2016