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About the Role

Develop and execute regulatory affairs (RA) activities from development to life cycle management, collaborating with global and Japan stakeholders. This role focuses on post-marketing activities, overseeing and managing the delivery of regulatory deliverables while complying with applicable regulations. It involves coaching staff, leading Health Authority interactions (e.g., PMDA or MHLW), managing change control processes, handling electronic Japanese Package Inserts, and representing RA for SOP updates.

Responsibilities

Oversee, manage, and mentor staff to ensure regulatory deliverables are met in compliance with regulations.
Provide coaching and development opportunities to staff.
Lead RA-related Health Authority interactions.
Lead Partial Change Application/Minor Change Notification processes with the CMC team.
Lead electronic Japanese Package Inserts, respond to queries, and participate in artwork activities.
Review promotion materials.
Manage outsourcing vendors.
Represent RA for SOPs/WI updates and improvement tasks.

Requirements

Extensive experience and knowledge in Regulatory Affairs, especially post-marketing activity.
Experience and knowledge of collaborating with cross-functional teams and global members.
People management skills.
Stakeholder management skills.
Communication/coordination skills.
Leadership/ownership skills.
Strategic consideration skills.
Project/risk management skills, including clarifying regulatory risks and planning/executing minimization/mitigation.

Skills

Regulatory Affairs
Post-marketing activity
Cross-functional team collaboration
Global team collaboration
People management
Stakeholder management
Communication
Coordination
Leadership
Ownership
Strategic consideration
Project management
Risk management

Location

Japan

Work Type

Full-time

Experience Level

Extensive experience

About the Company

Merck is a company driven by science and technology, with a passion for innovation.
Merck's solutions in healthcare, life science, and electronics enrich people's lives.
Merck is committed to building a prosperous world where people, customers, patients, and the planet coexist.
Merck fosters a diverse and inclusive culture that promotes excellence and innovation.
Merck is committed to creating access and opportunities for everyone to grow and develop at their own pace.
Merck's healthcare division focuses on uniting to support life's beginnings, improve quality of life, and sustain life.
The healthcare team develops pharmaceuticals, intelligent devices, and innovative technologies for oncology, neurology, and fertility.
The healthcare team collaborates across six continents with passion and relentless curiosity to help patients at every stage of life.

Equal Opportunity

We are committed to building an inclusive and belonging culture where everyone can support the advancement of humankind.
We create access and opportunities for everyone to grow and develop at their own pace.