Our client is a busy consulting company that supports life sciences companies, such as pharmas and biotechs, in product development across Europe and the USA. They are seeking a Director of Regulatory to join their team in Switzerland.
Job Role and Responsibilities:
- Write, review and provide regulatory input during the development of documents intended for regulatory submissions including CMC, nonclinical and clinical documents
- Oversee the process of responding to the FDA, and other US Regulatory Agencies if necessary, and support combined submissions for the EU and US
- Manage, coach and develop team members based in the Cambridge office, by maintaining current knowledge of US guidance and regulations and sharing that information among the team
- Participate in client meetings where strategy and planning are discussed and or where specialized expertise is needed
- Respond to new and existing clients inquiries within the Boston based biotech hub and outside the area as opportunities present themselves
- Meet with new clients as applicable to extract their current needs and to discuss additional corporate competencies that may broaden the scope of their partnership with us
- Prepare and deliver effective presentations for external and internal audiences as needed including conferences in candidate's area of expertise
- Define new areas of development for the company and present strategies for introducing new services that will benefit the biotech community
Education, Skills and Experience:
- Scientific and Drug/Biologic Development and/or Related Regulatory background
- 8-10 years proven professional experience in the USA
- Familiarity with 21 CFR and FDA Guidance related to pharmaceutical drug development
- Direct experience with successful interactions with the US FDA submissions and meetingsA
- bility to lead teams and apply problem solving skills
- Ability to prepare regulatory strategies to support drug development activities
- Proactive and enthusiastic approach to collaboration with internal staff and client teams
- Proficient writing skills, excellent verbal communication and presentation skills
- Excellent working knowledge of MS Office (Word, Excel, PowerPoint) is essential
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Latifah Khan on +44 203 8234 367 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.