Associate Director, CMC Regulatory Affairs

Role Summary

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. Our team is driven by strategic excellence, collaborative spirit, and a commitment to delivering high-quality regulatory outcomes. We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program. This individual will provide strategic regulatory direction and manage CMC activities in close partnership with cross-functional development teams, ensuring compliance with global regulatory standards and alignment with internal program goals. This position is eligible for a hybrid workplace model with onsite work at our Waltham, MA office and is not eligible for fully remote work.

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 investigational and registration submissions (INDs, IMPDs, NDAs, MAAs and amendments) in alignment with Health Authority requirements.
• Work within the department and cross-functionally to establish regulatory CMC strategies for product development and commercialization.
• Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate.
• Lead teams in preparation of responses to Health Authority related queries through cross functional collaboration.
• Develop strategies and lead teams in the preparation of key CMC related Health Authority meetings, including development of meeting information packages.
• Foster relationships and proactively communicating with key stakeholders.
• Develop and implement best practices based on current/emerging industry trends and relevant Health Authority guidance and regulations.

Skills

• In-depth understanding of relevant Health Authority regulations, guidelines and regulatory 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 their potential impact on Alkermes’ 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.
• Commitment to continuous improvement and best practices.
• Ability to manage multiple priorities in a fast-paced environment.

Qualifications

• Required: 7+ years of experience in the pharmaceutical/biopharmaceutical industry, including direct experience in drug development.
• Required: 3+ years of direct experience in Regulatory Affairs CMC, including Regulatory CMC lead experience.
• Preferred: Proven track record leading global regulatory CMC strategies across different stages of product development.
• Preferred: Proven ability to lead and manage junior Regulatory CMC team members is a plus.

Education

• Bachelor of Science in a scientific discipline; post graduate degree preferred.