Senior Regulatory Scientist

This is a fully remote position, open to applicants in Japan.

📋 Description

• Lead or play a significant role in developing regulatory strategies for clinical programs and key milestones.

• Draft and review intricate regulatory documents, such as clinical trial applications, briefing papers, and major submission components.

• Analyze global regulations, guidelines, and precedents; advise cross-functional teams on regulatory expectations and associated risks.

• Engage in or spearhead interactions with health authorities, including preparation for meetings, presentation assistance, and follow-up actions.

• Offer regulatory insights into clinical development plans, risk management strategies, and labeling considerations.

• Mentor junior regulatory personnel and contribute to the establishment of internal standards, templates, and best practices.

• Create regulatory-related documentation (various meeting materials, clinical trial applications, etc.).

• Collaborate with authorities and manage various tasks related to new drug applications from submission to approval.

• Provide advisory services from a regulatory perspective in collaboration with other internal departments.

• Propose and present regulatory strategies.

• Approach clients for new business acquisition.

• Prepare CMC-related documents and provide comprehensive CMC consulting.

• Share business-related notifications and regulatory updates with the team.

• Collaborate with the Manager and multiple team members to address business projects.

⛳️ Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.

• Significant experience in regulatory affairs or regulatory science within the pharmaceutical, biotech, or CRO sectors.

• Strong knowledge of global clinical development regulations and guidance, including those from the FDA, EMA, and ICH.

• Exceptional scientific writing, analytical, and critical-thinking abilities, emphasizing meticulous attention to detail.

• Proven track record of supporting or leading interactions with health authorities and managing complex submissions.

• Strong communication and collaboration skills, with the ability to work efficiently in cross-functional teams.

• Willingness to travel as necessary, approximately 5% of the time.

• Over 3 years of practical experience in negotiations and communication with regulatory authorities, ensuring smooth interactions.

• Proficient communication skills in English, including document creation capabilities.

• Business-level proficiency in the English language.

• Proficient in Microsoft Word, Excel, and PPT for professional use.

• Experience with literature research utilizing Copilot is a plus.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.