Job Description
This is a rare opportunity to join a young, exciting clinical-stage biotechnology company.
Our client is a clinical-stage neuroscience company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of progressive, life-threatening diseases
The Director, CMC Regulatory Affairs will be responsible for leading CMC regulatory filings and communications for INDs, IMPDs, pre-IND and scientific advice meetings, and other submissions as applicable, for investigational products, which may include monoclonal antibodies, vaccines and/or small molecules. The successful candidate will oversee and monitor US, EU, and other regional CMC regulatory commitments, managing and executing all activities in compliance with current regulations and standards.
Job Spec
- Lead the planning, preparation, review and submission of CMC regulatory filings, including INDs/IMPDs, amendments, scientific advice briefing documents and responses to information requests from regulatory agencies
- Define CMC regulatory strategies to enable timely and effective submissions for initial INDs/CTAs, responses to regulatory requests, required amendments, annual updates and other filings as needed
- Lead CMC regulatory review and approval for drug substance and drug product specifications, stability programs and related processes and procedures, as needed
- Provide CMC regulatory leadership in interactions with FDA and EMA, CMO vendors, internal global regulatory affairs, technical operations and cross-functional teams to facilitate alignment on CMC regulatory strategies, optimal approaches for their implementation, and timely completion of associated regulatory filings
- Maintain and expand working knowledge of applicable CMC regulatory requirements and precedents to inform regulatory approaches for early through late-stage development investigational products, providing updates to teams and/or functional areas as needed
Person Spec
- Advanced or Bachelors degree in a scientific or life sciences discipline
- Minimum 7 years of CMC pharmaceutical/biotech experience, with a focus on biologics
- Ability to manage all aspects of CMC regulatory activities from pre-CTA/IND through late-stage clinical development, including oversight of regulatory contractors, as needed
- Effective partnership with Global Regulatory Affairs, Technical Operations, CMOs and regulatory agencies; product registration/commercial experience a plus
- Demonstrated experience in the preparation, submission and maintenance of CMC regulatory filings in collaboration with project teams, including original INDs/CTAs, amendments and Scientific Advice
- Prior regulatory experience with EMA and FDA; global regulatory experience preferred
- Track record of effective collaboration on project teams, and across multiple organizational levels and functions
- Ability to build and maintain effective internal and external relationships, including cross-functional teams, regulatory agencies and contract organizations
- Excellent planning and organizational skills, including the ability to support and prioritize multiple projects, as needed
- Demonstrated ability in effectively applying current CMC regulatory requirements across product pipeline
- Must display strong analytical and problem-solving abilities
- Excellent written and verbal communication skills essential
Cv to gerry@rftgroup.ie 01 2302400