The Life Science Career Network
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for Regulatory Writer for a permanent role, based in Basel area.
The ideal candidate should have a minimum of 10 years of previous experience in Global Regulatory Affairs, specifically with competence in transparency and disclosure activities.
- Managing the creation and maintenance of policies, processes, templates and best practices to meet current and future regulatory writing, clinical trial disclosure and data transparency requirements
- Responsible for training and be the force behind change management
- Excellent in regulatory writing, clinical trial disclosure and data transparency activities within Regulatory Writing & Clinical Transparency
- Managing, overseeing and executing of PLS preparation within Regulatory Writing & Clinical Transparency
- Cross functional working within IT, implementing technology solutions related to regulatory writing and clinical trial disclosure and data transparency
- Leading or support selection and contracting of external service providers to support delivery of Regulatory Writing & Clinical Transparency activities
- Providing oversight of vendor activities, manage, and track book-of-work, and compile and report on volume and performance metrics, as appropriate
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Advanced degree in life sciences or related discipline (MSc/PhD or equivalent)
- A minimum of 10 years of relevant pharmaceutical/scientific experience, preferrable with at least 5 years of relevant regulatory writing experience
- Advanced knowledge of global regulatory environment and submission processes
- Excellent in global clinical transparency regulations
- Exceptional written and verbal communications skills in English
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.