Nora Ukaegbu MS-RA, BSc.

Regulatory Affairs Specialist I at Berkshire Sterile Manufacturing
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Contact Information
us****@****om
(386) 825-5501
Location
Boston, Massachusetts, United States, US
Languages
  • Igbo and English -

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5.0

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Amanda McEwen

Nora was a student in my course on the electronic Common Technical Document (CTD), a required course for the Master of Science in Regulatory Affairs for Drugs, Devices, and Biologics at Northeastern University. Nora's work in this course demonstrated her clear grasp of the material and ability to expand on assignment topics by making connections between the CTD course material and other relevant material from other courses in her Master's program. Nora carefully completes her assignments and actively sought feedback on her work, which she was able to successfully incorporate. Equally impressive was Nora's ability to manage the swift transition from in-person to online-only classes as a result of the onset of the pandemic, which is an excellent example of her ability to effectively adapt to change. I highly recommend Nora for work in the Regulatory Affairs space. Within any Reg Affairs team, Nora will bring an excellent foundational knowledge in the global Regulatory Affairs world as well as a willingness/ability to learn quickly and work diligently!

LinkedIn User

I taught Nora in our Therapeutic Product Development course. Nora demonstrated tremendous aptitude for the material and consistently and accurately applied the knowledge from our lessons to the real world situations we discussed. Nora also frequently stayed after class to further discuss material and provided her own perspectives based on her background and work experience. I know Nora will adapt easily to any position in the industry, and I offer my highest recommendation to support her.

LinkedIn User

Nora Shows Genuine Commitment to work and she has unbiased awareness of what she’s good at and what she can improve on. She’s intrinsic motivated when it comes to Pharmaceuticals sales marketing and product development, Nora has proven to be a legend and her work still speaks for her. She’s a Good Team player, Very flexible, hardly will you find her in the shadows. Most importantly she’s reliable and responsible,active listener and she Keep her team informed. she’s always ready to help, support and respect others.

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Credentials

  • Experiential Network
    Northeastern University
    Feb, 2021
    - Nov, 2024
  • Certification: Abbreviated New Drug Review Process
    FDA
    Jul, 2020
    - Nov, 2024
  • Introduction to FDA Human Drug Review and Approval Process
    FDA
    Jul, 2020
    - Nov, 2024
  • HSP
    CITI Program
    May, 2022
    - Nov, 2024
  • Good Clinical Practice (GCP)
    CITI Program
    May, 2022
    - Nov, 2024
  • RAPS Student Member
    Regulatory Affairs Certification Program
    May, 2021
    - Nov, 2024

Experience

    • United States
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Regulatory Affairs Specialist I
      • Jul 2022 - Present

      Skills: Regulatory Strategy . Document Review . Regulatory Submission . Quality Assurance . Research . Project Management . Timeline Management · Regulatory Operation · Document Management . Audit Investigation . Technical Writing . Communication. Skills: Regulatory Strategy . Document Review . Regulatory Submission . Quality Assurance . Research . Project Management . Timeline Management · Regulatory Operation · Document Management . Audit Investigation . Technical Writing . Communication.

    • Project Coordinator
      • Jan 2022 - May 2022

      • Developed a drug marketing strategy that generated prescriptions and increased the company's monthly sales target by 100%. • Analyzed the business territory and positioned drug products to expand the company's market presence and increase client base. Skills: Strategic Planning . Portfolio Management . Market Analysis . Organization . Time Management . Product Knowledge . Communication . Client Service. Marketing • Developed a drug marketing strategy that generated prescriptions and increased the company's monthly sales target by 100%. • Analyzed the business territory and positioned drug products to expand the company's market presence and increase client base. Skills: Strategic Planning . Portfolio Management . Market Analysis . Organization . Time Management . Product Knowledge . Communication . Client Service. Marketing

  • AGTC (Contract)
    • Massachusetts, United States
    • Regulatory Affairs Associate
      • Oct 2021 - Dec 2021

      • Maintained and reviewed regulatory documents to ensure compliance with regulatory requirements. • Estimated, planned, and developed timelines to coordinate different drug development projects and ensure timely submission to regulatory agencies. • Coordinated assembly of documents and collaborated with external contractor for Pediatric Investigation Plan (PIP) submission to the EU and MHRA. • Conducted research on regulatory requirements and guidelines to develop and implement regulatory strategies. • Collaborated cross-functionally with departments for task delivery that drives workflow for my team goal. • Prepared team meeting agenda and minutes, and coordinated after-meeting requests, events, and follow-ups to support drug projects. Skills: Regulatory Strategy . Project Management . Timeline Management . Regulatory Submission . Document Review . Regulatory Operation . Team Collaboration . Research . Oral Communication. Cross-functional Team Collaboration Show less

    • United States
    • Biotechnology
    • 1 - 100 Employee
    • Regulatory Affairs Intern
      • Jan 2021 - Apr 2021

      • Developed regulatory strategy and prepared guidelines for IND application which enabled the company’s decision-making and planning. • Researched and assembled information for clinical trial project preparation and planning. • Developed regulatory strategy that facilitated timely Pediatric Investigation Plan (PIP) submission applicable in the EU. Skills: Regulatory Strategy . Time Management . Planning . Research . Project Management • Developed regulatory strategy and prepared guidelines for IND application which enabled the company’s decision-making and planning. • Researched and assembled information for clinical trial project preparation and planning. • Developed regulatory strategy that facilitated timely Pediatric Investigation Plan (PIP) submission applicable in the EU. Skills: Regulatory Strategy . Time Management . Planning . Research . Project Management

    • Medical Representative and Drug Monitoring
      • Apr 2012 - Sep 2019

      - Detailed and marketed prescription drugs to achieve 100% assigned territory sales target. - Executed effective safety monitoring of drug products and reporting within timeline. - Managed and established assigned drug portfolio of antimicrobials, anti-diabetics, cardiovascular drugs, probiotic, NSAIDs, and hormonal drugs to increase company finance. - Increased territory client base and maintained effective follow-up to retain clients. - Increased the company's revenue through consistent 100% promotion and sales achievements. - Established effective structure for drug development projects, institutional registrations, document management and follow up. Show less

Education

  • Northeastern University
    Master's Degree, Regulatory Affairs for Drugs, Biologics, and Medical Devices
    2019 - 2021
  • Abia State University, Uturu Abia State Nigeria
    Bachelor of Science - BSc., Microbiology, General

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