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Regulatory Affairs Associate (Cpt/Opt)

1-3 years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

Katalyst HealthCares & Life Sciences Inc. is an E-Verified organization hiring entry-level candidates for contract research in clinical trials of drugs, biologics, and medical devices. We support professionals on OPT and CPT, and offer H1B (CAP and CAP exempt) and Green Card sponsorships for eligible candidates. Our opportunities span Regulatory Affairs Operations, CMC, Publishing, and Submission roles in clinical and non-clinical areas, in collaboration with university hospitals, pharmaceutical companies, and recruiting partners.


Position Overview

Role: Regulatory Affairs Associate
Location: Remote/Onsite
Job Type: Contract


Responsibilities

  • Regulatory Submissions:

    • Prepare, assemble, and submit ANDAs, amendments, supplements, and annual reports to regulatory agencies.
    • Create and manage submissions in eCTD and non-eCTD formats.
    • Coordinate responses to FDA Deficiency Letters and other regulatory agency queries.
  • Documentation Management:

    • Manage document preparation, publishing, and archiving for regulatory submissions.
    • Review submission documents critically, providing feedback to relevant departments for revisions.
  • Compliance & Coordination:

    • Stay updated on regulatory compliance standards and contribute to the development of departmental procedures.
    • Collaborate with cross-functional teams such as Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Research & Development to ensure seamless submission processes.
  • Technical Support:

    • Utilize eCTDXpress for submission publishing via ESG.

Qualifications

  • Education:

    • BS or MS in a scientific discipline or equivalent education and experience.
  • Experience:

    • 1-3 years in the pharmaceutical industry, preferably in Regulatory Affairs, Analytical, Quality Assurance, Research & Development, or Production.
  • Technical Knowledge:

    • Familiarity with US Regulatory Operations and submission processes.

Additional Information

  • All information will be handled confidentially in adherence to EEO guidelines.