Regulatory Affairs Specialist – Regulatory Scientist

• Support the Regulatory Lead in developing and executing integrated global and/or regional regulatory strategies for assigned programs across development and post-approval maintenance.
• Contribute to compiling regulatory documents for submission to Health Authorities.
• Support submissions including iPSPs/PIPs, ODDs, Briefing Books, INDs/CTAs, BLA/MAAs and sBLA/Variations.
• Lead or support collaboration with subject matter experts to provide timely responses to Regulatory Agency queries while maintaining consistency with the agreed regulatory strategy.
• Develop understanding of the regulatory environment, competitor intelligence and therapeutic area landscape, and apply insights to regulatory strategies.
• Identify and assess regulatory risks and contribute to mitigation strategies.
• Act as backup or delegate for the Regulatory Lead within project teams or workstreams.
• Review clinical trial plans, protocols and submission plans where applicable to ensure regulatory alignment.
• Provide regulatory input and follow-up for inspections, audits, litigation support and product complaints.
• Support development and continuous improvement of regulatory submission processes.

• University degree in a scientific or biomedical field.
• Minimum 3 years’ experience in a clinical development environment, preferably within Regulatory Affairs.
• Independent and able to learn quickly.
• Highly self-motivated with a hands-on approach.
• Excellent interpersonal skills, with the ability to build effective relationships across a diverse range of stakeholders.
• Strong leadership and critical-thinking skills, with the ability to work collaboratively to solve problems and make decisions.
• Sound judgement and the ability to analyse situations and information, making decisions based on facts and evidence.
• Demonstrated leadership within the context of assigned responsibilities.
• Able to communicate effectively within teams, with guidance and support from management.
• Excellent organisational skills and strong attention to detail.
• Able to prioritise effectively within a fast-paced environment.
• Proactive and collaborative, with the ability to drive assignments forward across teams.
• Working knowledge of current global clinical trial regulations.
• Able to summarise content for focused and maintenance submissions and provide training to others on submissions.
• Flexible mindset, with the resilience to adapt to changing priorities and regulatory strategies.
• Able to travel based on business needs.

• Fully remote work arrangement