Major Accountabilities:
· Prepare, edit, and finalize regulatory CMC documents related to DS, DP, and device required for regulatory submissions e.g. Module 3 BLA and IND, IMPD amendments, responses to questions, and annual reports.
· Collaborate with internal Technical Operations colleagues and external organizations to support timely execution of regulatory submissions that require CMC content, contributing to planning activities as needed.
· Support the tracking and maintenance of regulatory filings and databases related to CMC submissions.
· Ensure all documents comply with applicable regulatory requirements (FDA, EMA, ICH) and internal standards.
· Ensure consistency across documents using company templates and style guides.
· Support QC and review processes to maintain accuracy and quality.
· Contribute to the development and optimization of processes, SOPs, and templates for controlled documents.
· Maintain awareness of current regulatory requirements and precedents in the CMC regulatory landscape.
Job Requirements
Education: First degree in life sciences required; advanced degree (PhD or Masters) preferred.
Experience:
· A minimum of 3 years experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry or consultancy.
· Experience and knowledge in preparation of CMC sections for INDs, CTAs, and marketing applications is required.
· Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations.
· Experience working with recombinant proteins is highly desirable.
· Experience working with drug-device combination products is highly desirable.
Skills/knowledge/behavioural competencies:
· An understanding of the drug development life-cycle from clinical trials to marketing is required.
· Ability to understand and clearly communicate on topics of basic science is essential.
· Strong attention to detail, structured work style, and time management.
· Commitment to high-quality and timely deliverables.
Work Location: 2 days a week in our brand new Cambridge or Porto Office(s).
