Associate Director, CMC Regulatory Affairs at Alkermes, Inc. in Waltham, MA

Overview:

Great Science. Deep Compassion. Real Impact.

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.
Minimum of 7–8 years of relevant regulatory experience.
Relevant regulatory experience in post-approval CMC changes is required.

Preferred Requirements:

Experience in drug development is preferred.

#LI-HB1

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.