【Alexion Japan】Associate Director, Regulatory

Job Description

Position Summary

Associate Director, Regulatory Affairs is accountable for overall pharmaceutical affairs associated with development, implementation and maintenance of regulatory strategies for assigned product(s)/project(s) in Japan with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

This individual will provide tactical and strategic input to leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives.

The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

The duties include complying with Japan pharmaceutical affairs act, developing good relations with the regulatory authority.

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 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.).
• 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.
• Ensure exemplary behavior, leadership, ethics and transparency within the Enterprise, with Health Authorities and other external stakeholders.

Qualifications

• Minimum 7 years work experience in RA including more than 1 products approval experience as JRA leader
• Advanced Japanese language skil

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)

• Advanced in English in the Corporate setting. Additional languages are a plus

Date Posted

Closing Date

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 [email protected]. Alexion participates in E-Verify.