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Sr Reg Affairs Spec

8+ years
Not Disclosed
10 Dec. 6, 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

Regulatory Affairs Lead

Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office

Make an Impact in Global Regulatory Affairs
Join Thermo Fisher Scientific as a Regulatory Affairs Lead, where you will drive innovative regulatory solutions to support the development and authorization of clinical trials worldwide. You will provide strategic regulatory intelligence, guide product development from preclinical stages to post-registration, and ensure compliance with global standards.

Key Responsibilities:

  • Lead regulatory efforts across multiple countries and projects, ensuring timely and efficient submission processes.
  • Collaborate with PPD site intelligence, activation, and clinical management teams to streamline the regulatory 'green-light' process for investigational product shipment and site activation.
  • Review and approve essential documents to ensure compliance with GCP and applicable local/national regulations.
  • Verify key global documents, including:
    • Principal Investigator’s CV
    • Ethics committee approvals and ICFs
    • Regulatory authority approval documentation
    • Protocol signature pages, FDA forms, and financial disclosures
    • Other country-specific documents as needed

Education and Experience:

  • Bachelor’s degree or equivalent in a relevant field.
  • Minimum of 8+ years of experience in regulatory affairs, providing knowledge, skills, and abilities to perform the job effectively.

Skills and Abilities:

  • Excellent written and oral communication skills in English, with proficiency in local language as required.
  • Strong attention to detail and exceptional editorial/proofreading abilities.
  • Proven interpersonal skills for effective teamwork and acting as a liaison between departments.
  • Solid computer skills, with proficiency in Microsoft Word, Excel, and PowerPoint.
  • Excellent organizational, time management, and planning abilities.
  • Strong negotiation and independent judgment skills for assessing sponsor regulatory needs and ensuring compliance.
  • In-depth understanding of global, regional, and national regulatory requirements for clinical trial authorization, licensing, and lifecycle management.
  • Expert knowledge of ICH guidelines and regulatory specialty areas (preclinical, clinical, CMC, publishing, etc.).

Why Thermo Fisher Scientific?
Be part of a world-leading organization committed to advancing global clinical research and delivering life-changing therapies. At Thermo Fisher, you’ll thrive in a collaborative environment where your expertise and contributions will make a direct impact on improving global health outcomes.

Shape the future of clinical trials with Thermo Fisher. Apply now!