Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction.
We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio of proprietary marketed products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, and neurological disorders.
Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs supports a portfolio of small molecule development programs and marketed products across multiple locations and is committed to providing the best strategy through dedicated teamwork, professional excellence, and collaboration at every opportunity.
The Associate Director of CMC Regulatory Affairs will support post-approval CMC (Chemistry, Manufacturing, and Controls) changes, as well as global Supply Chain and GMP activities for Alkermes' marketed products. The role involves developing and leading regulatory CMC strategies focused on external product life-cycle improvements, while collaborating with cross-functional teams and external partners.
This position requires a hybrid work arrangement at our Waltham, MA office, and is not eligible for fully remote work.
Key Responsibilities:
Provide regulatory strategies and guidance on post-approval CMC topics.
Represent Regulatory Affairs on cross-functional committees, project teams, and vendor/contractor meetings.
Collaborate with key stakeholders (Quality, External Operations, and Manufacturing) to ensure compliance with regulatory requirements.
Lead the preparation, review, and submission of regulatory CMC documentation and dossiers.
Review and approve change controls, assessing regulatory impacts of product and process changes.
Coordinate responses to CMC-related queries from Health Authorities.
Offer regulatory and scientific expertise in writing and reviewing applications to ensure compliance and successful filings.
Manage regulatory relationships with external CMOs and third-party packaging suppliers, assessing regulatory impact of proposed changes.
Develop Health Authority meeting materials.
Drive initiatives to enhance regulatory standards and practices within the organization.
Monitor regulatory changes and communicate their impact to internal teams.
Develop and implement best practices based on industry trends and Health Authority guidances.
Skills and Abilities:
Deep understanding of global regulatory standards (FDA, EMA, TGA, Health Canada, ICH, WHO).
Expertise in regulatory CMC areas, including FDA requirements for INDs, NDAs, DMFs, and sNDAs.
Ability to interpret and resolve issues within the framework of SOPs, CFRs, regulatory guidelines, and cGMPs.
Strong writing skills, with attention to producing high-quality regulatory documents.
Excellent verbal communication and attention to detail.
Ability to work independently under tight deadlines in a dynamic environment.
Experience working in cross-functional or matrix teams, with strong problem-solving and decision-making skills.
Ability to adapt to shifting priorities and influence regulatory decisions.
Commitment to continuous improvement, identifying risks, and escalating issues to Regulatory management and/or key stakeholders, as necessary.
Basic Requirements:
Bachelor's degree in a scientific discipline required; post-graduate degree preferred.
Relevant regulatory experience in post-approval CMC changes is required.
