Associate Director, CMC Regulatory Affairs

Alkermes•Waltham, MA

42d•Hybrid

About The Position

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 be responsible for providing strategic regulatory direction and managing CMC related 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, requiring work to be completed onsite at our Waltham, MA office. This role is not eligible for fully remote work.

Requirements

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.
Bachelor of Science in a scientific discipline; post graduate degree preferred
7+ years of experience in the pharmaceutical/biopharmaceutical industry, including direct experience in drug development.
3+ years of direct experience in Regulatory Affairs CMC, including Regulatory CMC lead experience required.

Nice To Haves

Proven track record leading global regulatory CMC strategies across different stages of product development.
Proven ability to lead and manage junior Regulatory CMC team members is a plus.

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 submission (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.