Senior Manager, Regulatory Affairs Operations

The Senior Manager, Regulatory Operations will report to the Director of Regulatory Operations and will be responsible for submission management across the development pipeline and support the commercial portfolio. The position will collaborate and interface with Regulatory Affairs, cross-functional teams, and related vendors to provide regulatory submission support, expertise, and overall technical guidance. The Manager, Regulatory Operations will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases.  

Responsibilities: 

• Collaborate with Regulatory Affairs and cross-functional teams to plan for global health authority submissions, including overall timelines and deliverables. 

• Manage and communicate with submission vendor on timelines and document hand-offs.

• Lead and support all regulatory submission types and ensuring they are compiled accurately and within specified timelines while maintaining high quality.

• Support the implementation of regulatory systems and tools, including migration and testing.

• Managing all document and submission types to be uploaded, maintained, and archived. 

• Provide technical expertise to Regulatory Affairs and cross-functional teams as needed. 

• Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases. 

• Training of cross functional team members on submission processes to ensure compliance of standard operating procedures and health authority guidance and requirements. 

Knowledge / Skills / Qualifications: 

• Knowledge of IT systems and electronic submission requirements and processes. 

• Detail oriented with exceptional organizational skills. 

• Very strong PC / technical skills.

• Strong troubleshooting skills.

• Able to accomplish work independently and as part of a team. 

• Able to set and meet deadlines but flexible with changing timelines.

• Determine task priority and ensure deadlines are met.

• Team player as demonstrated by good communication and collaboration skills. 

• Strong interpersonal skills, including the ability to remain calm, professional, and positive. 

• Exercise confidentiality. 

Basic Qualifications:  

• At least least 5-7 years of direct experience in Regulatory Operations

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The annual base salary for this position ranges from $133,774 to $148,260. 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  

Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. 

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.