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Regulatory Systems Consultant

5+ 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 is currently hiring entry-level candidates for various positions in contract research related to clinical trials involving drugs, biologics, and medical devices. We provide immediate job opportunities in Drug Safety, Pharmacovigilance, and Clinical Research, partnering with university hospitals, pharmaceutical companies, and recruitment agencies.


Job Description

Position: Regulatory Submissions Specialist

As a Regulatory Submissions Specialist, you will be responsible for handling regulatory documentation, ensuring compliance with eCTD standards, and collaborating with cross-functional teams to facilitate successful submissions. Your expertise will contribute to maintaining high-quality standards in regulatory submissions and Chemistry, Manufacturing, and Controls (CMC) processes.


Must-Have Skills

  1. Regulatory Submissions
  2. eCTD (Volume 3)
  3. Pharma Chemistry Manufacturing and Controls (CMC)

Nice-to-Have Skills

  1. Strong documentation capabilities
  2. Effective communication skills

Education and Certifications

  • BS/MS in Life Sciences, Pharmacy, Biotechnology, or relevant experience

Responsibilities

  • Address and resolve issues related to:
    • DocSet
    • Market View
    • Supporting Documents
    • Market Impact Assessments
    • Document Outlines
    • Product Change Forms (PCF)
    • Metadata
    • Reporting
  • Perform data updates, including:
    • Metadata corrections
    • Creation of change control forms
    • Market and impact assessments in collaboration with strategists and SMEs
    • Development and setup of product dossiers
  • Provide periodic updates to stakeholders to ensure smooth communication and progress tracking.

Experience

  • 5+ years in regulatory submissions, CMC, or related fields

Additional Information

All applicant information will be kept confidential under EEO guidelines