Associate Director, CMC Regulatory Affairs

1w1 week ago

Alkermes

Waltham, US · Full-time · $172,000 – $187,000

About this role

Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. The team is driven by strategic excellence, collaborative spirit, and commitment to high-quality regulatory outcomes. We seek an experienced Associate Director to serve as Regulatory CMC Lead for a late-stage small molecule development program.

This role provides strategic regulatory direction and manages CMC activities in close partnership with cross-functional development teams. Responsibilities include ensuring compliance with global regulatory standards and alignment with internal program goals. The position requires onsite work at the Waltham, MA office under a hybrid model, not eligible for fully remote.

Day-to-day involves leading CMC strategy execution, overseeing submissions like INDs, IMPDs, NDAs, and MAAs, and preparing risk assessments. Collaboration with technical and regulatory teams supports product development and lifecycle management. Fostering stakeholder relationships and communicating proactively are essential.

The environment emphasizes cross-functional teamwork and strategic excellence in a fast-paced setting. Opportunities include developing best practices from industry trends and Health Authority guidance. Continuous improvement and influencing decisions drive professional growth in CMC regulatory affairs.

Requirements

In-depth understanding of relevant Health Authority regulations, guidelines and trends (FDA, EMA, TGA, Health Canada, ICH, WHO)
In-depth knowledge of drug development process within pharmaceutical and/or biopharmaceutical industries
Monitor global developments in CMC regulations, guidelines, and industry trends to evaluate impact on products
Good judgement in identifying risks and elevating issues to Regulatory Management
Advanced writing skills with ability to deliver high quality regulatory documents
Ability to influence decisions and help develop solutions
Excellent oral communication skills
Ability to manage multiple priorities in a fast-paced environment

Responsibilities

Lead regulatory CMC strategy and execution for assigned development programs
Provide regulatory and scientific expertise to shape CMC strategies for development programs
Collaborate cross-functionally with technical and regulatory teams to support product development and lifecycle management
Oversee preparation, review and submission of high-quality CMC sections for INDs, IMPDs, NDAs, MAAs and amendments
Work cross-functionally to establish regulatory CMC strategies for product development and commercialization
Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned
Lead teams in preparation of responses to Health Authority queries through cross-functional collaboration
Develop strategies and lead teams for key CMC Health Authority meetings, including meeting packages