You will support the Regulatory Manager with activities including but not limited to IMPD/IND submission support, regulatory authority communications, regulatory strategy and project management.
The Regulatory Specialist reports directly to the Regulatory Manager.
Job Responsibilities
- Maintaining, drafting and reviewing regulatory submissions, technical files, labelling and product documentation in support of my clients ATMP clinical trials (IND/IMPD).
- Ensuring that the content, quality, and format of regulatory submissions complies with applicable regulations and guidelines
- Supporting the timely responses to questions and other regulatory authority communications (e.g. orphan drug requests, PRIME applications, pre-IND communications). Maintaining positive relationships with internal and external regulatory contacts
• Developing and maintaining internal processes to facilitate compliant dossier life cycle management
- Supporting the development of global regulatory strategies and implementation plans for the preparation and submission of new products ensuring regulatory project deadlines and performance standards are established and met and aligned across my clients departments
- Staying up to date with relevant guidance and regulations impacting my clients products and ensuring timely communication to relevant departments
- Participating in project teams providing regulatory expertise to cross functional teams and project management. Ensuring compliance with regulatory agency regulations and interpretations
• Supporting the release of products to clinical trials and assessment of changes.
• Contributing to continuous improvement of internal processes
• And any other jobs as delegated by line manager
Education, skills and experience
The job as Regulatory Specialist will be held by a person with strong project management as well as regulatory experience.
- Bachelor’s degree and 2-5 years demonstrated regulatory affairs experience (clinical IND/IMPD - Biologics or ATMP preferred)
• +3 years additional relevant experience but latest being regulatory
• Familiarity with EU and US clinical legislation procedures (IMPD/IND) and guidelines governing
Biologics/ATMPs.
• Strong computer skills, project management skills, and a high attention to detail
- Team player that can work independently with demonstrated good organization and time management skills and ability to manage tight timelines when required
• Outstanding communication skills, both verbal and written in English.
Experience of ATMP/Gene and Cell therapy experience, eCTD, EU and or US IMPD/IND process experience, Lean 6 Sigma and GMP are an advantage.