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About the Role

Act as a key person to coordinate CMC and/or regulatory science issues between global and Japan so that appropriate solutions are provided. This role connects global development and Japan's regulatory requirements to support drug approval. You will lead CMC (Chemistry, Manufacturing and Controls) and regulatory science issues between global and Japan project teams. You will appropriately reflect global development plans and the latest CMC information into Japan's submission strategy, and provide feedback on Japan's pharmaceutical and CMC requirements to global stakeholders. Utilize scientific expertise and regulatory knowledge to identify development plan risks early and guide actionable solutions in collaboration with stakeholders.

Responsibilities

Be responsible for preparation of AAF, QOS and module 3 for Japan submission
Be responsible for preparation of answers to CMC inquiries from PMDA
Closely contact with global CMC/molecule leader so that the most updated CMC status/information is shared
Assess regulatory compliance of materials and their specifications (API, excipients and product) in advance for initiating Japan project
Provide key information of CMC regulatory guidelines to global counterpart so that appropriate CMC strategy is developed
Collection and share scientific, technical-related and specialized information from inside and outside resources
Identify critical scientific/technical issues well in advance to avoid or minimize the risk for development plan
Perform CMC regulatory assessment in change control process
Develop and expand active communication link within Japan project team to initiative good collaboration
Collaborate global business development regarding new licensing-in compounds on CMC area.
Lead the organization and adjustment of issues related to CMC and regulatory science between global and Japan.
Support the planning and execution of appropriate solutions in collaboration with stakeholders.
Provide important information on Japan's CMC regulatory guidelines and requirements to the global team.
Support the development of an appropriate CMC strategy based on Japan's requirements.
Lead the creation of AAF, QOS, and Module 3 required for Japan submission.
Confirm and organize CMC information provided by global teams and reflect it in content suitable for Japan submission.
Ensure the quality and consistency of submission documents in collaboration with stakeholders involved in development, manufacturing, and quality.
Consider the response policy for CMC-related inquiries from PMDA.
Collect necessary information from stakeholders such as global CMC, development, manufacturing, and quality.
Create response documents and promote them to submission, including review and coordination with stakeholders.
Evaluate the regulatory compliance of raw materials and specifications such as API, excipients, and products before the start of the Japan project.
Identify scientific and technical issues that may affect the development plan early.
Evaluate the risks that issues pose to the development plan and consider avoidance and mitigation measures.
Conduct CMC regulatory assessments in the change control process.
Collect scientific, technical, and specialized information from internal and external resources.
Organize and share collected information with stakeholders.
Promote active communication within the Japan project team.
Contribute to smooth project promotion by strengthening collaboration between teams.
Evaluate the CMC area for new license-in candidate compounds in collaboration with the global business development team.
Confirm CMC information, technical challenges, and development risks of candidate compounds.
Support the examination of development and submission possibilities in Japan.

Requirements

Practical experience related to drug development, such as CMC, regulatory affairs, manufacturing, quality, or R&D.
Knowledge and experience in CMC or regulatory science.
Experience coordinating technical and scientific issues between global and Japan teams.
Ability to read and accurately understand English technical and regulatory documents.
Ability to collect information from stakeholders, organize issues, and promote projects.

Skills

CMC
Regulatory Science
Drug Development
Pharmaceutical Affairs
Manufacturing
Quality Assurance
Quality Control
R&D
Communication
Risk Management
Project Management
Collaboration
Problem Solving
Scientific Writing
Regulatory Compliance
Technical Assessment
Information Gathering
Strategic Planning
Cross-functional Collaboration
English Proficiency

Location

Japan

Work Type

Full-time

Experience Level

Professional
Mid-level

Education Level

Bachelor's Degree
Master's Degree
PhD

Benefits

Personal development and career advancement opportunities
Diverse, inclusive, and flexible work culture
Opportunities for growth and development

About the Company

Merck is a global science and technology company.
Merck's solutions enrich people's lives in healthcare, life science, and electronics.
Merck is passionate about building a prosperous world where people, customers, patients, and the planet coexist.
Merck fosters a culture of curiosity.
Merck's healthcare purpose is to unite for patients, support the creation of life, improve quality of life, and sustain life.
Merck develops pharmaceuticals, intelligent devices, and innovative technologies in disease areas such as oncology, neurology, and infertility.
Merck's teams work collaboratively across six continents with passion and relentless curiosity to help patients at all stages of life.
Merck is composed of a group of curious people with diverse backgrounds, perspectives, and life experiences.
Merck believes this diversity drives excellence and innovation, strengthening leadership in science and technology.
Merck is committed to creating access and opportunities for everyone to grow and develop at their own pace.
Join Merck to build an inclusive and belonging culture that impacts millions and enables everyone to support the advancement of humankind.

Equal Opportunity

Merck is committed to creating access and opportunities for everyone to grow and develop at their own pace.
Join Merck to build an inclusive and belonging culture that impacts millions and enables everyone to support the advancement of humankind.