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2+ 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 Specialist

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

At Thermo Fisher Scientific, you will embark on meaningful work that positively impacts global health. Our mission is to enable customers to make the world healthier, cleaner, and safer. Join us in advancing science through research, development, and the delivery of life-changing therapies.

Through our PPD® clinical research services, we conduct clinical trials in 100+ countries and develop novel frameworks for research, ensuring health outcomes improve worldwide. Our Regulatory Affairs team delivers regulatory science services to accelerate innovation, improve decision-making, and bring therapies to patients faster.

Discover Impactful Work
As a Regulatory Affairs Specialist, you will provide strategic regulatory intelligence and support product development from preclinical stages through registration and optimization. You’ll collaborate with internal and external clients to deliver compliant, high-quality solutions that align with global and regional regulatory requirements.

Key Responsibilities:

  • Support the preparation of documentation and submissions under guidance.
  • Coordinate and manage client deliverables to ensure regulatory compliance.
  • Liaise with clients and teams to track project progress and support timelines.
  • Assist in budgeting, forecasting, and maintaining knowledge of SOPs and regulatory guidelines.
  • Engage in business development, project pricing, and evaluating client needs.
  • Resolve issues to ensure timely delivery of regulatory deliverables.

Qualifications:
Education:

  • Bachelor’s degree or equivalent qualification.

Experience:

  • 2+ years of relevant regulatory affairs or related experience.

Skills and Abilities:

  • Strong English communication skills; proficiency in local languages is a plus.
  • Attention to detail with excellent editorial and proofreading skills.
  • Effective team collaboration and independent work capabilities.
  • Knowledge of Microsoft Office Suite and ability to learn new tools.
  • Understanding of global regulatory requirements and clinical trial processes.
  • Familiarity with medical terminology and statistical concepts.

Join Thermo Fisher Scientific to make a difference in regulatory science and the delivery of innovative therapies to patients worldwide.