Alkermes · 1 month ago
Associate Director, CMC Regulatory Affairs
Greater Boston
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$172K/yr - $187K/yr
7+ years expAlkermes is a fully-integrated, global biopharmaceutical company committed to developing medicines for complex psychiatric and neurological disorders. They are seeking an experienced Associate Director of Regulatory Affairs CMC to lead regulatory strategy and manage CMC activities for late-stage small molecule development programs, ensuring compliance with global regulatory standards.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
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
Preferred
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
Benefits
Annual performance pay bonus
Competitive benefits package
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-09
2026-01-06
Company data provided by crunchbase