Director, Regulatory Affairs for Clinical Studies
vor 1 Woche
Location: Root D4, CH, 6039Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.
For our office in Root, Switzerland, we are looking for a
**Director, Regulatory Affairs for Clinical Studies**
As Director Regulator Affairs, you will be part of and leading a function within the global regulatory affairs team. Your main goal will be to guarantee that the processes required by the standards and applicable regulations (Europe, Japan, Canada, USA and China as well as other countries) are in place and applied by the company.
Essential Duties & Responsibilities:
- Being focused on the clinical studies regulatory compliance, responsible for obtaining and maintaining regulatory approvals for clinical studies in various countries.
- Providing guidance on regulatory, as well as QA issues related to clinical studies
- Managing regulatory projects, with focus on tasks related to clinical studies.
- Being a part of the global regulatory affairs team, responsible to obtaining and maintaining regulatory approvals in all the relevant markets.
- “hands on” - writing and reviewing of documents is part of the role, including writing or reviewing SOPs related to establishment of new process in the company.
- Specific areas of activity:
- Maintaining and updating registration and any formal documentation needed for the clinical and commercial medical devices from Swissmedic, as needed.
- Maintaining and updating registration and any other formal documentation needed for the clinical and commercial devices from other Competent Authorities in EU (either directly or through service provider).
- Maintaining and updating registration and any other formal documentation needed for the clinical and commercial devices from other Competent Authorities in North or Latin America, APAC countries as needed.
- Setting up a controlled procedure to follow up and update clinical core clinical documents as needed.
- Take part in the MDR implementation process.
- Coordinate and guide clinical operations to uphold regulatory compliance in clinical studies.
- Assist in preparing regulatory submissions in EU and globally, as needed.
Required Skills & Competencies:
- Master's degree in life sciences, health technology or an engineering degree;
- Over 10 years’ experience in the medical device or pharmaceutical industry
- Possess at least 15 years’ or more experience in Regulatory Affairs in the medical device industry with strong clinical studies background
- Team management experience is required
- Strong familiarity with clinical studies requirements and operation for drugs, medical devices or combinations
- Substantial experience in collaborating with Health Authorities and ECs/IRBs
- Experience in project management and in team management
- Experience working in a QA unit is preferred.
- Superb attention to detail and excellent communication skills
- Collaborative and independent working style
- Ability to organize, plan and adjust work assignments while meeting deadlines;
- Eager to learn and learn quickly;
- Excellent English (written and spoken, other European languages an advantage);
- Office software proficiency.
Please find more information about Novocure and our therapy on our website or by consulting our patient testimonial videos.
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