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Regulatory Affairs Technical Author

2 months ago

New York, New York, United States SSi People Full time

Essential Qualifications:

  • SSi People is open to considering candidates who can operate 50% onsite at any designated location.
  • Onsite requirement: 50% (Week 1 - 3 days; Week 2 - 2 days)
  • A Bachelor's degree in Chemistry, Biology, or a related scientific field is strongly preferred.
  • Prior experience in clinical or regulatory documentation is advantageous.
  • A background in scientific research, particularly in Pharmacokinetics and Bioanalytics, is preferred.
  • Experience with regulatory submissions is a plus.

Key Responsibilities:

  • Collaborate with Subject Matter Experts (SMEs) in Drug Metabolism and Pharmacokinetics (DMPK) and Bioanalytical (BA) fields to create, review, and manage regulatory documents. This includes, but is not limited to, INDs, CTAs, NDAs, BLAs, IBs, Pediatric Investigative Plans, and regular updates of such documents. Regulatory submissions will encompass various therapeutic areas (oncology, immunology, neurology, etc.) and modalities, including small molecules, large molecules, and cell therapies.
  • Support multiple global drug development initiatives, working on programs intended for various international markets.
  • Assist in the quality assessment of DMPK reports generated by scientists by thoroughly reviewing raw data outputs and electronic notebooks, ensuring the validity and quality of reported data in the documentation. This includes reviewing DMPK regulatory documents and editing nonclinical study reports to ensure compliance with company standards, SOPs, DMPK/BA methodologies, and applicable regulatory guidelines.
  • Engage with Health Authority inquiries related to DMPK and BA in collaboration with SMEs and regulatory representatives.
  • Establish and oversee document timelines through the authoring and review processes to ensure timely completion.
  • Participate in departmental meetings to track and manage upcoming requirements for nonclinical documentation.
  • Comprehend the implications of DMPK/BA and their interconnections with other functional teams within the organization, including Pharmacology, Toxicology, Clinical, and Regulatory disciplines.
  • Perform additional related duties as assigned within SSi People.