Regulatory Affairs Specialist/Regulatory Scientist - FSP

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Regulatory Affairs Scientist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to support Regional and/or Global Regulatory Leads in developing and executing regulatory strategies for assigned programs. As a Regulatory Affairs Scientist, you’ll contribute to global and regional programs across development and post-approval maintenance, helping ensure regulatory activities and submissions are aligned with applicable requirements and the overall regulatory strategy. You’ll work collaboratively with Regulatory Leads, subject matter experts and cross-functional teams, contributing to regulatory submissions, Health Authority interactions, risk assessment and regulatory planning while developing your expertise across the global regulatory environment. What You’ll Do: • Support the Regulatory Lead in the development and execution of integrated global and/or regional regulatory strategies for assigned programs across development and post-approval maintenance. • Contribute to the compilation of 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, ensuring content remains consistent with the agreed regulatory strategy. • Develop your understanding of the regulatory environment, competitor intelligence and therapeutic area landscape, and apply these insights to the development of regulatory strategies. • Identify and assess regulatory risks associated with specific strategies and contribute to defining appropriate mitigation strategies. • Act as a backup or delegate for the Regulatory Lead within project teams or workstreams, helping maintain alignment and a consistent “one regulatory voice.” • As applicable, review clinical trial plans, protocols and submission plans for assigned projects to ensure alignment with regulatory requirements. • Provide regulatory input and follow-up relating to inspections, audits, litigation support and product complaints. • Support the development and continuous improvement of processes related to regulatory submissions. Education and Experience Requirements: • University degree in a scientific or biomedical field. • Minimum 3 years’ experience in a clinical development environment, preferably within Regulatory Affairs. Knowledge, Skills and Abilities: • 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.