Regulatory CMC Senior Manager _ Biopharma

YOUR 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 key responsibilities will include leading discussions and actions towards shared goals within the team, preparing critical documents such as the AAF, QOS, and Module 3 for Japan submissions, and crafting comprehensive responses to CMC inquiries from the PMDA. You will maintain close communication with global Regulatory CMC colleagues to ensure that the most up-to-date CMC status and information are shared. Additionally, You will assess the adequacy of CMC information (API, excipients, drug product) content based on Japanese regulatory requirements and provide key CMC information to our counterparts around the world, as well as propose and coordinate development strategies in Japan. 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. Currently, our team consists of three people, and this position will be a playing manager with no direct reports. This position is based in Japan and offers flexible remote work options up to two days a week.

WHO YOU ARE

You have 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.

You possess professional experience in CMC activities, such as formulation development, analytical development, and API and drug product manufacturing.

You have a solid understanding of ICH guidelines and Japanese CMC-related regulations, particularly for regulatory submissions.

You are familiar with global pharmaceutical product development processes and possess strong business acumen.

You have experience leading global projects and fostering collaboration among diverse teams.

You demonstrate excellent communication skills, both written and verbal, in English and Japanese.

You have a proactive mindset, with the ability to influence and encourage colleagues to work cohesively towards common objectives.

You are skilled in collecting and sharing scientific and technical information from various internal and external resources to enhance project outcomes.