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2+ years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Full Time Remote 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 Associate

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

Make an Impact with Thermo Fisher Scientific
At Thermo Fisher Scientific, you'll be part of a global team making a positive impact through research, development, and the delivery of life-changing therapies. With clinical trials conducted in over 100 countries, we are redefining clinical research through innovative frameworks that span laboratory, digital, and decentralized services. Join us and play a vital role in improving global health outcomes.

Key Responsibilities:

  • Provide regulatory expertise and strategic intelligence to support product development, from preclinical through to registration and optimization.
  • Prepare client deliverables ensuring compliance with current regulatory and technical requirements, both local and global.
  • Coordinate and manage client deliverables, tracking project plans and providing overall support for regulatory compliance.
  • Assist in business development efforts, including project budgeting, forecasting, and pricing.
  • Collaborate with cross-functional teams to deliver final products and resolve project issues, ensuring timely delivery.
  • Maintain up-to-date knowledge of SOPs, client directives, and regulatory guidelines to ensure adherence to industry standards.

Education & Experience:

  • Bachelor’s degree or equivalent in a relevant field.
  • At least 2+ years of experience providing the skills and knowledge to perform regulatory tasks effectively.

Skills and Abilities:

  • Strong communication skills in English (written and oral), with proficiency in local language when applicable.
  • Excellent attention to detail, editorial/proofreading skills, and ability to maintain high quality.
  • Strong interpersonal and teamwork skills for effective collaboration.
  • Proficiency in Microsoft Word, Excel, PowerPoint, and an eagerness to learn new technologies.
  • Strong organizational, time management, and planning skills to manage multiple projects and priorities.
  • Basic understanding of regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management.
  • Good problem-solving skills and the ability to interpret complex data.

Why Thermo Fisher Scientific?
Join a team committed to improving global health outcomes. At Thermo Fisher, you'll have the opportunity to work in an environment that encourages professional growth, continuous learning, and the chance to make a direct impact in the world of clinical trials.

Apply Now and contribute to making the world healthier, cleaner, and safer with Thermo Fisher Scientific.