【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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.