Group Manager - Regulatory Affairs

外資系企業上場企業大手企業英語力が必要土日祝休み

募集要項

募集背景: Overview:
Pipeline and On-Market Products Development and Maintenance from Regulatory perspectives
● Responsible and accountable for new product introduction and sustain product operation activity.
● Plan and execute necessary activities relating to medical devices and drugs.
● Manage regulatory activities relating to specific portfolio of products/projects

仕事内容: Key Responsibilities:

Report to Head of QARA
Registration and maintenance of Medical Devices and Drug

● Develop and execute regulatory plans aligned with business strategy for complex projects including new products and maintenance of regulatory files for existing marketed products
● Identify & prioritize key areas of risk, and develop & implement appropriate mitigation plans
● Establish appropriate communication within RA, with global Marketing, and with other functions at project level and favor proactive communication
● Ensure Registration strategy and deliverables are aligned with project teams and business objectives
● Lead regulatory activities related to their portfolio of products
● Prepare, review, and approve labeling, J-CTD based on global dossier and in cooperation with PV/MDS and confirm sufficiency of total submission dossier package for approval
● Represent or lead the RA function on assigned cross-functional project teams
● May participate external advocacy activity and contribute internal environment improvement
● May provide direct supervision of individuals
● Monitor applicable regulatory documentation and propose solutions. Identify areas for improvement
● Develop and document sound regulatory decisions and justification

応募資格

必須: Skills & Experiences:

● Scientific (Chemical) or pharmaceutical background as well as regulatory knowledge (at least BA). Masters and/or PhD will be advantage.
● Experience of medical device registration (minimum 5 years).
● Experience of pharmaceutical drug filing (supportive activities would be acceptable).
● Management skills.
● Experience to prepare CTD Quality part (CMC RA)
● Demonstrated interpersonal skills including negotiation skills
● Ability to multitask and prioritize
● Establish relationship with regulatory authorities
● English skills: strong written, verbal communication and presentation skills (e.g., TOEIC: above 700 or 800)
● Experience worked for foreign companies is desirable

事業内容・会社の特長: A global healthcare organization renowned for its commitment to advancing medical solutions and improving patient outcomes. With a rich history dating back several decades, this company operates on a global scale, offering a diverse portfolio of products and therapies across various healthcare domains.

Primarily focusing on lifesaving and sustaining solutions, this company specializes in developing and manufacturing a wide range of medical products. These include intravenous (IV) solutions, infusion systems, and other critical medical devices that play a vital role in patient care and treatment. The organization is dedicated to addressing the evolving needs of healthcare professionals and patients, with a focus on innovation and cutting-edge technology.

With a global presence, this medical company collaborates with healthcare providers, institutions, and professionals to deliver high-quality, reliable healthcare solutions. Its commitment to diversity, equity, and inclusion is evident in its workforce and corporate culture. The company values the diverse perspectives of its employees, fostering a collaborative and inclusive environment.