CMC manager
About this opportunity
Career Category
Regulatory
Job Description
Group Purpose
To facilitate product development by developing and executing the regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
Job Summary
Regulatory CMC Japan Manager is responsible for execution of the Japan-specific product strategies align with the global strategy. This position prepares and submits NDA/CTD/PCA/MCN/consultation dossiers in collaboration with Global Reg CMC and Operations, and may need support from the local Senior Manager partially. This position provides CMC information of investigational products used in clinical trials to local Dev Ops and external vendors.
Key Activities
Prepare CMC components in NDA/CTD/PCA/MCN/consultation dossiers for Amgen products in collaboration with the Senior Manager, Regional and Global Reg CMC
Prepare and update CMC document for CTN in collaboration with Regional and Global Reg CMC
Participate in Project Teams and PST as an Local CMC expert
Interact with Japanese Health Authorities
Provide CMC information for investigational products and medical devices used in clinical trials in Japan
To facilitate cross functional (with JAPAC RA-CMC, Japan RA, Japan QA etc) matters
Knowledge and Skills
CMC-specific local regulatory knowledge & experience
Biologics-specific regulatory knowledge & experiences
Chemical products specific regulatory knowledge & experiences
Communication skills in Japanese and English
Team player
English conversation, read, and writing
Computers: Microsoft Outlook/ Word/ Excel/Power Point/Project
Education & Experience (Basic)
Over total 10 years experience for regulatory CMC and/or CMC (Operation) of pharmaceutical industry including biologics for supporting PMDA consultation, CTN and NDA submission in Japan
Education & Experience (Preferred)
Master or Doctor degree
.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 179 comparable Manager Regulatory Affairs roles across 65 biopharma companies.
Salary context
58 of 179 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 179 comparable roles
+ 21 more countries
Seniority mix
179 of 179 peers have a known seniority level
Therapeutic area mix
17 of 179 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.