Instagram
youtube
Facebook

Regulatory Affairs Associate

2+ years
Not Disclosed
10 Nov. 21, 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

Job Title: Regulatory Affairs Specialist – ANDA Submissions
Company: Katalyst Healthcares & Life Sciences
Location: [Location]
Contract Type: Contract

Company Overview:

Katalyst Healthcares & Life Sciences is hiring entry-level candidates for multiple positions in Clinical Trials, Drug Safety, Pharmacovigilance, and Clinical Research. We specialize in contract research for clinical trials of drugs, biologics, and medical devices, collaborating with university hospitals, pharmaceutical companies, and recruiting partners.

Job Description:

We are seeking a Regulatory Affairs Specialist to assist with the preparation and submission of Abbreviated New Drug Applications (ANDAs), Amendments, Supplements, and Annual Reports to regulatory agencies. The role involves supporting the regulatory function, including document management, electronic submission compilation, and managing other group activities as required. The successful candidate will collaborate with various departments, including Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Research and Development.

Responsibilities:

  • Assist in the preparation and submission of ANDA, Amendments, Supplements, and Annual Reports to appropriate regulatory agencies.
  • Support regulatory functions through document management, electronic submission compilation, and management activities.
  • Collaborate with cross-functional teams such as Regulatory Affairs, Quality Assurance, Manufacturing, Research and Development, Information Technology, and others as needed.
  • Prepare, assemble, review, and evaluate regulatory submissions in accordance with local regulatory requirements and guidelines.
  • Prepare eCTD and non-eCTD submissions for regulatory agencies and ensure timely delivery of quality submissions.
  • Review submission documentation critically and provide input for necessary revisions.
  • Coordinate responses to FDA Deficiency Letters and other agency requests.
  • Use eCTDXpress to complete submission publishing for submission through ESG.

Qualifications:

  • BS or MS in a scientific discipline or equivalent education and experience.
  • Minimum 3 years of work experience in the pharmaceutical industry, preferably in drug regulatory affairs, analytical, QA, R&D, or production.
  • Working knowledge of US regulatory submissions.

Additional Information:

  • All information will be kept confidential according to EEO guidelines.

Apply Now: Katalyst Healthcares Careers