【Alexion Japan】Director, Regulatory

Principal Responsibilities
 Accountable as Regulatory Lead to develop and implement regulatory strategies for assigned product(s)/project(s) in Japan and accountable to provide regulatory advice to cross-functional strategies and associated deliverables according to business objectives.
 Lead a regulatory product team responsible for developing and implementing strategies and executing for products and/or projects in Japan, aligned to overall Enterprise objectives and global regulatory strategies through initial registration and subsequent lifecycle management.
 Lead the planning and conduct of meetings and communication with the local health authorities in alignment with global regulatory and cross-functional strategy. Serving as a contact point for the company, coordinates pharmaceutical affairs matters on product development between internal concerned departments and regulatory authority.
 Accountable for the regulatory execution of submissions in the relevant regulatory jurisdiction, by actively collaborating with other Regulatory functions and cross-functional teams (e.g. clinical trial notifications , marketing authorization applications, orphan drug designation applications, etc.).

 Prepares various pharmaceutical regulatory affairs documents in a timely and appropriate manner according to the product development plan.
 Manages pharmaceutical regulatory affairs schedules for product development plan.
 Lead the Submission sub-team as a Japan Regulatory Lead of Japan Project Team and join the Global Regulatory Affairs sub team
 Main point of contact for relevant local HA inspections and support for interactions with relevant departments/functions for response(s) to local HAs
 Negotiates with subcontractors and external parties about pharmaceutical affairs issues as needed with Regulatory-Ope.
 Actively be up to date on latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca’s internal knowledge and expertise.
 Actively collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide portfolio or therapeutic level regulatory insight and broader drug development expertise.
 Supports relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support.
 Ensure exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders

Qualifications
 Minimum 9 years work experience in RA including more than 3 products approval experience as JRA leader
 Have an experience of people management as a Director of RA or equivalent experience
Education
 BA/BS degree (or equivalent) in life sciences (medical, pharmacy, veterinary medicine, science, engineering, agriculture, medical economics etc). MS preferred.

Competences
• Excellent use of Microsoft 365 (Office) tools, ideally well skilled on the use of PowerPoint
• Experience working in regulatory documentation system (like Veeva)
• Profecient in English in the Corporate setting. Additional languages are a plus

Date Posted

21-2月-2025

Closing Date

20-2月-2025

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

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