CMC Regulatory Lead, Biologics (Phase 3) - Hybrid Boston
Vivid Resourcing, Boston, Massachusetts, us, 02298
A clinical-stage biotech firm is seeking a Director/Senior Director of Regulatory Affairs, CMC to lead the regulatory strategy for a pivotal Phase 3 biologic therapy.
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.
This high-impact role requires 10+ years of Regulatory Affairs experience and proven success with late-stage submissions.
Responsibilities include defining the CMC regulatory strategy, preparing IND and BLA submissions, and engaging with global regulatory agencies.
Candidates should possess strong collaborative communication skills and a deep understanding of biologics manufacturing.
This position offers hybrid work flexibility and significant autonomy in a science-driven environment. xsgimln
Remote working/work at home options are available for this role.
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.
This high-impact role requires 10+ years of Regulatory Affairs experience and proven success with late-stage submissions.
Responsibilities include defining the CMC regulatory strategy, preparing IND and BLA submissions, and engaging with global regulatory agencies.
Candidates should possess strong collaborative communication skills and a deep understanding of biologics manufacturing.
This position offers hybrid work flexibility and significant autonomy in a science-driven environment. xsgimln
Remote working/work at home options are available for this role.