Site CMC Regulatory Director: Global Change & Submissions
usa 3316 takeda development center americasSomerville (MA)
Site CMC Regulatory Director: Global Change & Submissions
Posted yesterday
usa 3316 takeda development center americasSomerville (MA)
SENIORITY
Manager
About the role
Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval change management and regulatory submissions across small molecule and biologics. This role requires 10+ years in biopharma with deep global HA regulatory experience, an advanced scientific degree, and proven ability to communicate regulatory strategy to cross-functional teams.
The position offers a hybrid work arrangement, competitive compensation, and opportunities to drive standardization and
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.