Senior Regulatory Affairs Manager CMC

Job title: Senior Regulatory Affairs Manager CMC
A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical device (auto injector) experience.
Responsibilities:
for the development and execution of global regulatory CMC and device strategies and submissions, including CMC dossiers to support clinical trial applications and marketing applications
with internal Technical Operations colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, responses to questions, audits and inspections
the preparation, drafting, review, risk analysis and mitigation planning of CMC submissions e.g. Module 3 IND, IMPD, amendments and annual reports
Requirements:
in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry
and knowledge in preparation of CMC sections of INDs, CTAs, and marketing applications is required
knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations
working with recombinant proteins is highly desirable
interactions with health authorities such as scientific advice or agency meetings, including with FDA, is desirable
of first degree in life sciences (or equivalent); advanced degree (e.g. PhD or Masters) preferred.
Salary and benefits:
A highly competitive salary, stock options, annual bonus and wider benefits package is on offer
To apply for this position or hear further details then please contact Matt Thomas via #####