ãAlexion JapanãAssociate Director, Regulatory
ãAlexion JapanãAssociate Director, Regulatory
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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 AstraZenecas 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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.
Required Experience:
Director
Employment Type
Full-Time
