Center of Excellence Regulatory Lead
il y a 1 semaine
- managing the team of regulatory associates that performs regulatory oversight for the individual studies.
Key Accountabilities/Responsibilities:
- Maintain an indepth knowledge of the fastevolving global clinical trial regulations
- Develop and maintain a regulatory intelligence database to centralize handson knowledge on (local) regulations and internal experiences regarding clinical trial submissions
- Actively liaise with other functions involved in clinical trial submissions in order to optimize clinical trial startup timelines
- Advise clinical trial teams during study planning, setup and conduct
- Oversee the team of regulatory liaisons and ensure the appropriate regulatory oversight for all clinical studies
- Provide training to educate functional areas on regulatory changes and lessons learned
- Adapt and optimize processes related to clinical trial submissions to comply with new regulation(s) and gain efficiency
- Identify the need for new processes and develop these together with the relevant functional areas
- Develop, update and maintain procedural documents as needed
Desired Skills and Experience:
- Excellent communicator
- Builder of interdepartmental relations
- Working knowledge of current global clinical trial regulations
- Handson approach to support CTT team(s)
- Independent, quick learner
- Prioritize effectively in a fastpaced environment
- Excellent organizational skills and attention to detail
- Leadership skills and critical thinker to find solutions with the teams for various problems and make decisions
- Analytical mind to understand, analyse and optimize processes and procedures
- Highly selfmotivated
- Computer literacy, proficiency in MS Word, Excel, PowerPoint, Acrobat Pro, etc
- Master degree or PhD in scientific or biomedical field
- 10+ years of experience in clinical development role (preference given to regulatory affairs)
- Deep understanding of clinical trial submission process:
- Experience in the submission and maintenance of clinical trials worldwide
- Expert in the EU Regulation 536/201
- Experience with the US IND submission process
- Familiarity with clinical trial documents and clinical development design
- Experience in improving processes and update/create related Procedural Documents
- Experience with writing review summaries and developing training material
- Knowledge of project management
Offer:
- A competitive salary package with extensive benefits;
- A work environment in a successful, dynamic, rapidly growing biotech company.
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