Regulatory Scientist

Role Overview

• Under the guidance of the Senior Director, Regulatory Science, the successful candidate will support the Global and Regional Regulatory Lead(s) in the execution of regulatory activities primarily in EU/UK markets, linked to the lifecycle management and maintenance of marketing authorisations:
• Contribute to the preparation and/or review of the regulatory documentation to support the post-approval activities (variations, renewals, post-approval commitments and obligations, PSURs etc) to maintain marketing authorisations up-to-date and compliant in the assigned countries.
• Contribute to the preparation and/or review of submission packages (including CMC, clinical, pharmacovigilance documents) to regulatory authorities (including EMA and national regulatory authorities) for the assigned programs.
• Provide support to the Regional Regulatory Lead for the coordination and preparation of responses to questions and requests for information from regulatory authorities.
• Contribute to the preparation and/or review documentation required for labelling activities (for example: update of core company data sheet (CCDS), Investigator Brochure (IB), product information documents, educational material) in the assigned countries.
• Provide proactive support for product launch activities in relevant countries and support the maintenance of country-specific regulatory materials.
• Partner with the Regional Regulatory Lead to provide support to local partners for the post-approval maintenance activities in assigned ROW markets.
• Provide some support to Regional Regulatory Lead for marketing authorization applications in new ROW geographies (e.g. Latin America, Asia Pacific countries).
• Monitor, analyse, and disseminate intelligence on regulatory topics that may impact approved commercial products and specific geographies.
• Provide support to improve team standard operation procedures (SOPs) and to prepare internal audits and future Health Authority inspections.

Requirements

• An early regulatory career professional who has worked in EU/UK regulatory affairs, preferably supporting post-approval life cycle management activities, within industry or regulatory consultancies.
• Knowledge and understanding of EMA/MHRA requirements for preparation and submission of regulatory documentation (e.g. variations, PSUR, renewal) to support post-approval life cycle management activities in the EU/UK.
• Knowledge and/or experience in marketing applications or post-approval submissions for Gene Therapy or Cell Gene Therapy products is a plus.
• Ability to work in a cross-functional, multi-cultural team environment, and with remote teams.
• Strong attention to details.
• Ability to handle multiple tasks in parallel and prioritise effectively.
• Comfortable working in a fast paced and constantly evolving environment with an ability to adapt to program/activities changes.
• Strong collaboration mindset.
• Proven organisational, computer and documentation skills.
• General interest in a broad range of regulatory activities
• BSc degree or equivalent in life sciences. An advanced degree is highly desirable.
• Regulatory Affairs certification is a plus.