About the organisation

We’re pushing the boundaries of biotechnology to develop groundbreaking treatments for rare genetic disorders and personalized cancer therapies. Our mission is to transform patient care through innovative solutions, and we need your regulatory expertise to guide our products from the laboratory to the global market.

The Role

As our Regulatory Affairs Officer, you will play a pivotal role in ensuring our innovative therapies meet all regulatory requirements and reach patients as quickly and safely as possible. Your responsibilities will include:

• Preparing and submitting high-quality regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and Biological License Applications (BLAs)
• Developing and implementing global regulatory strategies for product development and marketing
• Reviewing and interpreting complex regulatory guidelines to ensure compliance with FDA, EMA, PMDA, and other international regulatory authorities
• Coordinating and managing regulatory submissions across multiple product lines and geographical regions
• Serving as the primary liaison between the company and regulatory agencies, including organizing and participating in regulatory agency meetings
• Supporting clinical development teams in designing studies that meet regulatory requirements
• Collaborating with cross-functional teams including R&D, Clinical Operations, Manufacturing, and Quality Assurance to ensure regulatory compliance throughout the product lifecycle
• Maintaining comprehensive regulatory documentation and databases in accordance with company standards and procedures
• Monitoring and analyzing regulatory trends and developments to provide strategic input on their impact on company products and pipeline
• Conducting regulatory intelligence activities to stay abreast of evolving regulations and guidances

Qualifications

The ideal candidate will possess:

• A bachelor’s or master’s degree in Regulatory Affairs, Life Sciences, Pharmacy, Biotechnology, or a related field; advanced degree preferred
• 2+ years of progressive experience in regulatory affairs within the biotechnology or pharmaceutical industry, with a focus on biologics and advanced therapies
• In-depth knowledge of FDA regulations, EMA guidelines, ICH requirements, and other relevant international regulatory frameworks
• Experience in preparing and submitting INDs, NDAs, BLAs, or MAAs
• Strong understanding of the drug development process, from preclinical research through post-marketing activities
• Excellent project management skills with the ability to manage multiple projects simultaneously
• Exceptional attention to detail and analytical skills
• Outstanding written and verbal communication abilities, with experience in drafting regulatory documents and correspondence
• Proven ability to interpret and summarize complex scientific and regulatory information
• Proficiency in regulatory information management systems and eCTD software
• RAC certification is a plus

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

Ryan Griffin