Job DescriptionRegulatory 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.
Key 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.
Skills and Abilities:- 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.
Basic Qualifications:- 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.
Preferred Qualifications:- 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.
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QualificationsThe annual base salary for this position ranges from $172,000 to $187,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
