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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 overseeing, managing, and mentoring staff to ensure regulatory deliverables are met while complying with applicable regulations. It involves leading Health Authority interactions, New Drug Application (NDA) submissions, and preparing regulatory documentation for Japan.

Responsibilities

Oversee, manage, mentor, and ensure that Group plans and delivers the regulatory deliverables as the representative of Group, while complying with applicable regulations.
Provides coaching and development opportunities to staff.
Lead RA-related Health Authority (HA) interactions.
Lead New Drug Application (NDA) and supplementary NDA (sNDA) such as indication expansion, new formulation, etc.
Lead preparation of the Japan NDA activities and HA’s review for approval.
Prepare the Japan-CTD regulatory parts such as Approval Application Form, Module 1, etc.
Lead electronic Japanese Package Inserts (J-PI), respond to query, and join artwork activities.
Review promotion materials.
Manage Outsourcing vendors as needed.
Represent RA for the SOPs/WI updates and improvement tasks.

Requirements

Extensive experience and knowledge in Regulatory Affairs, especially development activity.
Experiences and knowledge of Collaborating with cross-functional team and global member.

Skills

Japanese- native level.
English: Able to communicate with global members as J-RA representative.
People management skills
Stakeholder management
Communication/coordination
Leadership/ownership skills
Strategic consideration
Project/risk management skills (e.g., To Clarify regulatory risks and plan/execute minimization/mitigation).

Location

Japan

Work Type

Full-time

Experience Level

Extensive experience

Education Level

Education and Preferable work experiences

About the Company

At Merck, we are driven by curiosity and have been for the last 350 years. We are a vibrant, science and technology company with a rich history. We are united by a passion for innovation and a desire to make a difference in the lives of people around the world. Our solutions in Healthcare, Life Science and Electronics are helping to create a more sustainable and fulfilling future.
We are a group of curious people with diverse backgrounds, perspectives, and life experiences. We believe this diversity drives excellence and innovation, strengthening our leadership in science and technology.
We are committed to creating access and opportunities for everyone to grow and develop at their own pace.
Join us to build an inclusive culture of belonging where millions of people can be impacted and everyone can support the progress of humankind!

Equal Opportunity

We are committed to creating access and opportunities for everyone to grow and develop at their own pace.
Join us to build an inclusive culture of belonging where millions of people can be impacted and everyone can support the progress of humankind!