Nakia Vance
Sr Regulatory Affairs Specialist at Spark Therapeutics, Inc
Based in Philadelphia, United States
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Seniority
Staff
Department
Science
Location
Philadelphia
Industry
Biotechnology Research
Company size
1K
Contact information
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n•••••••@sparktx.com
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Background
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.
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