Regulatory CMC Senior Manager _ Biopharma
The businesses of Merck KGaA, Darmstadt, Germany · JP
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About the Role
This role provides a unique opportunity to make a significant impact in the pharmaceutical industry while working in a dynamic and supportive environment. As the CMC Regulatory Senior Manager, you will serve as a pivotal liaison between global and Japan teams, ensuring effective coordination of CMC and regulatory science issues. Your role is crucial in identifying potential scientific challenges and regulatory scientific gap early to mitigate risks in development plans, thereby supporting the company's mission of delivering innovative healthcare solutions.
Responsibilities
- Lead discussions and actions towards shared goals within the team.
- Prepare critical documents such as the AAF, QOS, and Module 3 for Japan submissions.
- Craft comprehensive responses to CMC inquiries from the PMDA.
- Maintain close communication with global Regulatory CMC colleagues to ensure that the most up-to-date CMC status and information are shared.
- Assess the adequacy of CMC information (API, excipients, drug product) content based on Japanese regulatory requirements.
- Provide key CMC information to counterparts around the world.
- Propose and coordinate development strategies in Japan.
- Identify potential scientific challenges and regulatory scientific gaps early to mitigate risks in development plans.
Requirements
- 7-10 years of experience in CMC NDA dossier preparation (CTD Module 2 and Module 3) and supplemental NDA submissions, including partial changes and PMDA CMC-related consultations.
- Professional experience in CMC activities, such as formulation development, analytical development, and API and drug product manufacturing.
- Solid understanding of ICH guidelines and Japanese CMC-related regulations, particularly for regulatory submissions.
- Familiarity with global pharmaceutical product development processes.
- Strong business acumen.
- Experience leading global projects and fostering collaboration among diverse teams.
- Excellent communication skills, both written and verbal, in English and Japanese.
- Proactive mindset, with the ability to influence and encourage colleagues to work cohesively towards common objectives.
- Skilled in collecting and sharing scientific and technical information from various internal and external resources to enhance project outcomes.
Skills
- CMC NDA dossier preparation
- CTD Module 2 and Module 3 preparation
- Supplemental NDA submissions
- PMDA CMC-related consultations
- Formulation development
- Analytical development
- API and drug product manufacturing
- ICH guidelines
- Japanese CMC-related regulations
- Global pharmaceutical product development processes
- Business acumen
- Global project leadership
- Team collaboration
- Written and verbal communication (English and Japanese)
- Scientific and technical information collection and sharing
Location
- Japan
Work Type
- Remote (up to two days a week)
- Hybrid
Experience Level
- Senior Manager