Job Description

We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Associate Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will provide strategic and tactical advice to teams to achieve support the development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. The ideal candidate will have a strong scientific background, and be able to leverage their experience to provide leadership within the department and across R&D.

This role reports to the Senior Director, Head of Orexin Regulatory Strategy.

• Contribute to development of robust, global regulatory strategies for assigned projects. Accountable for adapting and maintaining the regulatory strategy as needed
• Develop submission plans and timelines in accordance with project goals. Lead cross-functional efforts to deliver high quality submissions, and develop risk mitigation strategies
• Coordinate submission development, developing and authoring content as applicable. Direct subject matter experts in content development and authoring. Ensure documents take a data-driven regulatory approach
• Provide ongoing guidance to project teams
• Triage and coordinate responses to questions from regulatory authorities
• Participate in interactions with Health Authorities, interpret feedback, and ensure that the outcome is properly communicated to the Organization.
• Share best practices across the broader Regulatory Affairs organization
• Manage regulatory policy and intelligence activities, including commenting on guidance and monitoring the competitive and policy landscape for changes with potential impact

• Degree in life sciences; advanced degree preferred
• At least 6-10 years’ experience in the biopharma industry, preferably in neurology

• Experience as primary regulatory author for IND and CTA documents

• Strong knowledge of FDA, EMA, and ICH regulatory guidelines and eCTD structure
• Excellent oral and written communication skills; solid grasp of effective regulatory writing fundamentals and ability to communicate complex issues clearly and concisely
• Strong team player: the ability to work flexibly in a collaborative environment and assist team members as needed to achieve goals; able to be a situational leader when required
• Highly skilled at project managing regulatory workstreams, identifying the critical path for submissions, and partnering with functional leads to manage timeline risk
• Able to work independently on competing priorities in a fast-paced and dynamic environment; a creative thinker with good attention to detail

The annual base salary for this position ranges from $169,000 – $186,000. 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

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.