Company: Mitsubishi Tanabe Pharma
Location: Jersey City
Posted on: June 4, 2021
Spirit, Rooted in Tradition. At Mitsubishi
Tanabe Pharma Development America (MTDA), we can tout a storied
reputation more than 300 years in the making. Our parent company,
Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven
pharmaceutical company with global reach – and one of Japan’s
oldest and most respected companies.
MTDA is rapidly
expanding our operation across all functional areas to assist in
the research and development of new products for the U.S.
(Chemistry, Manufacturing and Controls) Consultant will support
implementation of MTDA local and global CMC strategies. He/she will
provide support for cross-functional collaborations to integrate
CMC programs for MTDA investigational products. The incumbent is
also responsible for leading aspects of CMC regulatory submissions
and will serve as an internal representative/contact for CMC
- Contributes to
development of programs/processes that support development of
Investigational or New Drug Applications.
with CMC counterparts in Japan and other departments to execute CMC
submission activities, including meeting requests and briefing
documents, for INDs/NDAs submitted to regulatory
timely preparation, review and submission of high-quality CMC
content for MTDA submissions of all types and their amendments and
supplements as assigned.
functional expertise and supports CMC related discussions,
negotiations and responses with FDA and internal stakeholders such
as Production Technology, Quality Operations, Commercial
manufacturing, Supply chain,
technical, and regulatory in Japan, as required, on CMC related
projects and issues.
Support global CMC process development and improvement as
Provides ongoing lifecycle support for marketed commercial
contributes to the outsourcing of manufacturing efforts and change
controls, the assessment of regulatory impacts, and provides
support for their implementation.
Regulatory Affairs CMC function, as required, at various
cross-functional team meetings and working group meetings,
providing solutions when possible to the project teams on CMC
related problems. Escalates more complex issues to the Sr.
up-to-date knowledge of relevant FDA and ICH requirements relating
to CMC activities.
updates teams on the impact of new legislation, regulations and
guidance on development plans and registration strategy as it
relates to CMC sections for INDs/NDAs.
- Minimum B.S. in
Pharmacy, Chemistry, Chemical Engineering or related field
(M.S. or Ph.D.) is preferred
years of experience in CMC activities including submissions to
regulatory agencies, interaction with regulatory authorities, and
CMC module development and review experience
knowledge of pharmaceutical development of drug substance and drug
FDA and ICH regulations/guidance as it applies to
working in a multi-cultural, multi-lingual environment, Japanese
company experience is preferred but not required
ability to contribute successfully in a multi-disciplinary team
environment / matrix organization
knowledge of DP and API GMP is preferred
MS Office, MS Project
No travel into
the office at this time; to be re-addressed and discussed based on
Keywords: Mitsubishi Tanabe Pharma, Jersey City , CMC Consultant, Other , Jersey City, New Jersey
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