Associate Director, Regulatory CMC
Posted on Apr 5, 2021 by ImmunoGen, Inc.
ImmunoGen, Inc. is in search of an organized and motivated team player to join our growing Regulatory Affairs department. This individual will be accountable for the regulatory CMC strategy to support the development and commercialization of oncology products across the company's portfolio. They will provide strategic planning and management of the development of regulatory CMC documents for submission (eg, IND/CTA/BLA/MAA).
Regulatory CMC lead for one or more project. Regulatory CMC representative in cross-functional teams (specifications/stability/change review) and project teams.
Independently develops and executes effective regulatory CMC strategy for the clinical development, registration and post-approval life cycle management of ADCs.
Defines CMC content and ensures the timely preparation of investigational and commercial CMC dossiers, CMC amendments and supplements and responses to questions from health authorities.
Assesses CMC change controls, evaluates the regulatory actions required and plans submissions.
Demonstrates understanding of regulatory guidance documents, regulations and directives and works with the CMC team to address and overcome CMC challenges.
Leads discussion on regulatory CMC topics with internal colleagues and external partners.
Identifies potential regulatory risks and exercises good judgment in communicating critical topics in a timely manner to appropriate stakeholders and management.
Who You Are
BA/BS in a scientific discipline with at least 8 years of experience in pharmaceutical regulatory CMC, or equivalent. Advanced degrees preferred.
Early (phase1) experience through initial market application phase. US and global experience and biologics experience preferred.
Experience with small molecules and commercial experience a plus.
Keeps abreast of current industry standards and techniques.
Regulatory CMC professional with strong CMC knowledge of Good Manufacturing Practices (cGMP), current US and EU regulations, guidances and current regulatory expectations
Strong organizational and project management skills. Ability to successfully deliver on agreed timelines on concurrent projects.
Strong verbal and written communication skills. Demonstrated success on cross-functional teams.
Expertise in ICH CTD structure and experience authoring Module 3 sections for US, Europe and Canada. Keeps abreast of evolving regulatory CMC expectations.
Ability to work effectively through cross-functional team to achieve results. Demonstrated team player with ability to influence others.
Proficiency with electronic document management systems, Microsoft Word, Excel, and PowerPoint.
Previous active participation in agency interactions and communication with health authorities required. Served as lead in those interactions preferred.