What are the responsibilities and job description for the Senior Manager, CMC Regulatory Affairs position at Katalyst CRO?
Responsibilities
- Actively participate on CMC development teams to plan regulatory strategies by defining pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately marketing approvals.
- Align CMC regulatory plans with cross-functional development and manufacturing teams.
- Execute regulatory strategies: track and manage progress within defined timelines.
- Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of assigned drug candidates.
- Independently and in collaboration with CMC team members, write Module 3 sections to support INDs, IMPDs, NDAs and MAAs.
- Critically evaluate health authority questions and lead the team of cross-functional SMEs to write responses.
- In collaboration with CMC team members, write questions and briefing documents in support of Health Authority meetings such as Type C meetings with FDA, and Scientific Advice meetings with EMA.
- Evaluate proposed manufacturing and quality changes for impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
- Facilitate the development of, reviews, and comments on all technically complex CMC documentation for submission to regulatory authorities including process development, process validation, analytical method development, and analytical method validation supporting establishment of specifications and in-process, release and stability data and information appropriate to phase of development.
- Manage processes: collaborate cross functionally with teams and departments to generate CMC regulatory documents including reviews and resolution of comments.
- Disseminate global CMC regulations and guidelines with appropriate interpretation.
- Minimum of BS or BA in a scientific or technical discipline, advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
- Industry experience of 8 years, of which at least 5 years spent in regulatory affairs with CMC responsibilities.
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including US FDA and international regulatory requirements (EMA, ICH, Health Canada, LATAM and others), guidance, accelerated regulatory review paths, and policy trends, with expertise in small molecule and oligonucleotide-based product development preferred.
- Proven track record of delivering in a biotech start-up, fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful.
- Expertise in navigating matrixed organizations and working effectively with all levels of management, cross-functional stakeholders, and individual contributors across the company.
- Experience with Veeva Vault is a plus.
