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Senior Regulatory Affairs Associate/Specialist

Company

SciPro
Address San Diego, CA, United States
Employment type CONTRACTOR
Salary
Category Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-07-29
Posted at 10 months ago
Job Description

Senior Regulatory Affairs Associate/ Specialist (12 months)

On-site San Diego, CA


We are partnering with an exciting biotech that is a leading oncology focused company dedicated to combatting breast, lung and prostate cancer. This team is passionate about making a difference and driving innovation. As a Senior RA associate/specialist, you will play a crucial role in ensuring compliance with regulatory requirements and supporting our product development and market authorization efforts.


Responsibilities:

  • Review documents necessary for the regulatory site documentation related to the shipment of drug products to clinical sites.
  • Maintain and manage databases containing regulatory information, submissions, and correspondence.
  • Stay updated on applicable US and global regulations, guidance, and standards pertaining to drug development and product registration.
  • Be able to provide support to regulatory management and project teams and implement regulatory strategy while delivering documentation on time.
  • In collaboration with a regulatory staff members you are expected to prep, gather, analyze, and submit various regulatory documents, such as INDs/BLAs/NDAs.
  • Independently plan daily work to complete time-sensitive assignments while following general instructions for project completion.
  • Communicate and collaborate with different departments and cross functional teams to gather and organize information required for submissions to regulatory agencies, adhering to FDA guidelines.


Qualifications:

  • Experience submitting IND filings utilizing eCTD formatted submissions highly desirable.
  • Adhere to sections 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines.
  • Ability to implement regulatory plans and strategies and proactively identify gaps and potential risks.
  • Solid background in drug development process and understanding of global guidance and regulations.
  • BS in life sciences with a minimum of 3 years of experience in Regulatory Affairs
  • Demonstrated ability to work effectively with cross-functional teams (ex: non-clinical, clinical, operations, med chem etc.)