The CMC Regulatory Manager is responsible typically for all R&D projects regard to CMC regulatory issues, reporting to solid line to Sr. Director, Global R&D Product Development and Market Liaison Japan and dotted line to R&D Head, in cooperation with project team. The CMC Regulatory Manager pro-actively works with members of the project team, identifying issues that might change strategy/plan or delay the project and making recommendations to improve time lines and the costs for project completion.

Major Accountabilities

l Preparing CMC regulatory documents and serving as in-house regulatory expert to global and local project teams.

l Providing relevant guidance and advice to expedite the manufacturing process while ensuring conditions for meeting regulatory requirements are maintained.

l Be responsible for maintaining up to date knowledge of regulatory affairs.

l Establish and carry out portfolio strategy at each assigned project to maximize returns on such portfolio management.

l Collaborate with global and local project team to build “one voice” concept into global portfolio strategy, and to ensure adherence to global portfolio guidelines while making balance with and implementing with local strategy.

l Key interfaces include: R&D Head; Market Assessment Head, Business Plan& Control Head, BD when necessary

Ideal Background

l University degree in pharmaceuticals or bioscience

l PhD degree in pharmaceuticals/bioscience preferred

l English both spoken and written

l Japanese as fluent

l Significant (>5 years) experience in CMC documents preparation with analytical chemistry experience a plus in the pharmaceutical industry.

l Must be experienced in CMC regulatory tools

l Must have knowledge of GMP and CMC guidelines

l Demonstrated ability to think broadly and innovate within the pharmaceutical business

l Proven ability to work effectively across a matrixes and widely-dispersed organization

l Excellent interpersonal, communication, and influencing skills

l Demonstrated facilitation skills and success

l Excellent analytical ability

l Working knowledge of pharmaceutical R&D procedures and trends, and thorough understanding of product- relevant bioscience bioscience

l Team oriented

l Age from late 30’s to late 40’s
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