- Be accountable for the delivery of regulatory affairs for the product portfolio including both strategy and operations as well as providing key input into non-clinical and clinical aspects of regulatory preparation, delivering a regulatory strategy for novel therapeutics in areas of high unmet need, including rare diseases.
- Provide guidance to internal multi-disciplinary teams (Non-Clinical functions, Biostatistics, Medical Affairs, Medical Writing and Pharmacokinetics) on the regulatory requirements to support clinical development and lead multi-disciplinary teams in the authoring of regulatory communications such as regulatory briefing packages, applications for Scientific Advice Meetings, Orphan Drug Designation, Paediatric Investigational Plans, etc.
- Accountable for the submission (either directly or through vendors) of high-quality regulatory packages for CTAs, INDs, with subsequent coordination and provision of responses.
- Working directly with the EMA, and other regulatory agencies (either directly or through vendors), managing the preparation for and attendance at assigned meetings, provision of responses etc.
- The development of best practices internally to support regulatory documentation readiness, and development and maintenance of regulatory SOPs as well as the effective management of development safety update reports.
- Taking the initiative to monitor, analyse and disseminate intelligence on regulatory policy and guidelines and make recommendations for impact to projects or organisational practices.
The ideal candidate for this role will have:
- Educated to degree level or above in life science or a related field with extensive experience of working at a senior level in the Pharmaceutical or biotech industries.
- Previous experience in leading Major Health Authority interactions (e.g. FDA advisory committee meetings, oral explanations, scientific advice, pre-NDA/BLA, EOP2 meetings, etc).
- Extensive experience of regulatory drug development including product approval/launch.
- Proven leadership and program management experience and the ability to think strategically and critically evaluate risks to regulatory activities.