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Regulatory Affairs Specialist

5+ years
Not Disclosed
10 Aug. 16, 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

Position: Regulatory Affairs Specialist

Location: Haifa, IL

Company Overview:

Novocure is a global, publicly traded oncology company at the forefront of developing a revolutionary cancer treatment called tumor treating fields (TTFields). TTFields is a non-invasive, innovative treatment modality designed to slow or reverse tumor progression by inducing tumor cell death. Our flagship product, Optune, is approved for treating glioblastoma (GBM) in the USA, Europe, and Israel. We are expanding our clinical trials into additional solid tumor indications, including non-small cell lung cancer and pancreatic cancer.

Job Description:

We are seeking a Regulatory Affairs Specialist to join our Global Regulatory Affairs team. This role will be essential in supporting regulatory documentation and submissions required to market new or modified medical devices. The Specialist will manage regulatory documentation throughout the product lifecycle, from development to post-market surveillance, and ensure compliance with international standards and regulations.

Key Responsibilities:

  • Prepare and manage documentation for global regulatory submissions in a timely manner.
  • Respond to regulatory queries from global regulatory authorities.
  • Organize and maintain records and correspondence related to regulatory documentation.
  • Ensure regulatory compliance through effective process maintenance and monitoring.
  • Research and provide guidance on regulatory issues and global regulatory intelligence.
  • Collaborate with cross-functional teams, including engineering, QA, supply chain, and clinical development, on various projects.

Qualifications and Knowledge:

  • Education: MSc degree in Life Sciences.
  • Experience: Minimum of 5 years in regulatory affairs and/or QA within the medical device or pharmaceutical industry.
  • Knowledge:
    • In-depth understanding of international regulations for the EU, US, Japan, China, and other jurisdictions.
    • Familiarity with ISO 13485.
    • Experience in writing procedures and regulatory documents.
    • Proficiency in English (both written and spoken); additional European languages are a plus.
  • Skills:
    • Strong attention to detail and ability to work under pressure to meet deadlines.
    • Critical thinking, reasoning, and problem-solving abilities.
    • Proficient in Office software.

Additional Attributes:

  • Excellent organizational and time management skills.
  • Highly motivated and quality-oriented.
  • Strong communication skills and ability to work effectively as part of a team.

About Novocure:

Our Vision:

Patient-forward: Aspiring to make a difference in cancer.

Our Mission:

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our Values:

  • Innovation
  • Focus
  • Drive
  • Courage
  • Trust
  • Empathy

For more information about Novocure and our therapies, visit www.novocure.com.