Associate Director, Regulatory Affairs

A multinational biopharmaceutical company is seeking an Associate Director, Regulatory Affairs. The selected candidate will lead regulatory strategies, submissions, and communications with health authorities while supporting cross-functional teams.

Responsibilities:

• Develop and implement regulatory strategies for assigned products and projects in Japan
• Lead meetings and communications with local health authorities aligned with global strategy
• Coordinate pharmaceutical affairs between internal departments and regulatory authorities
• Oversee regulatory submissions, including clinical trial notifications and marketing authorisation applications
• Prepare and manage regulatory documents and development schedules
• Lead Japan Regulatory Lead sub-team and support internal regulatory processes and inspections

Requirements:

• Bachelor’s degree or above in life sciences (medical, pharmacy, veterinary medicine, science, engineering, agriculture, medical economics etc.)
• More than 7 years of experience in RA
• Experience in regulatory documentation system (Veeva)
• Prior product approval experience as JRA leader
• Skilled in MS Office Suite
• Proficient in English and Japanese

About the Company:

A leading global biopharmaceutical company specialising in rare diseases, this organisation is driven by cutting-edge science and a deep commitment to transforming patients’ lives. With a strong focus on innovation and a collaborative culture, it offers job seekers the opportunity to make a real impact in a purpose-driven environment.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: 3QWN09