Principal Responsibilities
 Responsible as Regulatory Lead to develop and implement regulatory strategies for assigned product(s)/project(s) in Japan and responsible to provide regulatory advice to cross-functional strategies and associated deliverables while being supported or advised by other senior RAs.
 Make 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.
 Responsible 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.).
 Prepare various pharmaceutical regulatory affairs documents in a timely and appropriate manner according to the product development plan.
 Manage 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
 Negotiate 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.
 Support relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support.

Qualifications
 Minimum 5 years work experience in RA including 5 or more PMDA consultations or equal experience as JRA
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)
• Intermediate in English in the Corporate setting. Additional languages are a plus

Date Posted

Closing Date

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