[ref. q64637816] London - Director of Regulatory Affairs

Position: Senior Director of Regulatory AffairsContract Type: PermanentHours: Full-TimeLocation: Hybrid

Start date: ASAP

Job Description:

• Provide strategic and tactical input on pre-clinical, clinical, post-approval, and life cycle management, focusing on early registration in Japan.
• Develop and implement a Japanese regulatory strategy in coordination with global regulatory affairs and cross-functional teams.
• Lead interactions with Japanese health authorities, act as the main regulatory contact, and manage regulatory negotiations, consultations, and inspections.
• Develop key regulatory documents, including briefing documents, NDA submissions, and responses to Japanese HA questions.
• Ensure clinical protocols align with Japanese regulatory requirements, support CTA submissions, and coordinate responses to HA queries.
• Lead the preparation, review, and submission of key regulatory documents (J-NDA, ODD, Drug Master File, inspections, etc.), ensuring alignment with global strategy.
• Work closely with internal stakeholders (e.g., labeling teams, global regulatory leads) to support product development, compliance, and lifecycle management in Japan.

Job Qualification:

• B.S. or graduate degree in life sciences with 15+ years of regulatory affairs experience in Japan's pharmaceutical or biotech industry, covering multiple development phases.
• Extensive experience with PMDA/MHLW, including drug development, product registration, and marketing authorization processes.
• Proven track record in regulatory pathways for rare diseases and unmet medical needs (e.g., orphan drugs, fast track, Sakigake).
• Critical thinker with a problem-solving mindset, particularly in rare disease programs.
• Deep understanding of Japanese regulatory requirements, ICH guidelines, and global drug development frameworks.
• Strong planning, organization, and bilingual communication skills (English & Japanese); experience managing Japanese service providers.