Sr Manager, Regulatory Affairs

Alkermes; Boston (MA); On-site; USD 134,000 - 149,000; Full time

Benefits offered by this job

Hybrid work model

Performance bonus

Job summary

Alkermes is seeking a Senior Manager of Regulatory Affairs to guide regulatory strategies for new product development and clinical progression, reporting to the Head of Orexin Regulatory Strategy. The role focuses on strategic and tactical regulatory leadership within a global development framework.

The position supports submission planning, cross-functional collaboration, and responses to authorities, with a hybrid work model and onsite presence in Waltham, MA.

Qualifications

• Bachelor's Degree in life sciences; advanced degree preferred.
• 6-8 years’ experience in the biopharma industry, preferably in neurology.
• Experience with authoring regulatory information for IND and CTA documents.
• Strong knowledge of FDA and ICH regulatory guidelines and eCTD structure.
• Excellent oral and written communication skills; ability to communicate complex issues clearly and concisely.
• Strong team player; able to lead in a collaborative environment and manage timelines.

Responsibilities

• Contribute to development of robust, global regulatory strategies for assigned projects.
• Support submission plans and timelines; lead cross-functional submissions and risk mitigation.
• Coordinate submission development; author content; ensure data-driven regulatory approach.
• Provide ongoing guidance to cross-functional teams.
• Triage and coordinate responses to questions from regulatory authorities.
• Support interactions with Health Authorities; communicate outcomes to the Organization.
• Share best practices across the Regulatory Affairs organization.

Skills

Regulatory strategy

FDA regulations

ICH guidelines

eCTD experience

Regulatory writing

Project management

Cross-functional collaboration

Leadership

Communication skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Job Description

We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Senior Manager 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 Executive Director, Head of Orexin Regulatory Strategy.

Responsibilities

• Contribute to development of robust, global regulatory strategies for assigned projects.Accountable for adapting and maintaining the regulatory strategy as needed


• Support the development of submission plans and timelines in accordance with project goals. Lead cross-functional efforts to deliver high quality submissions, and develop risk mitigation strategies


• Support and 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 cross-functional teams


• Triage and coordinate responses to questions from regulatory authorities


• Support 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


• Support regulatory policy and intelligence activities, including commenting on guidance and monitoring the competitive and policy landscape for changes with potential impact

Qualifications

• Bachelor's Degree in life sciences; advanced degree preferred


• At least 6-8 years’ experience in the biopharma industry, preferably in neurology


• Experience with authoring regulatory information for IND and CTA documents


• Strong knowledge of FDA 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, strategic thinker with good attention to detail

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

The annual base salary for this position ranges from $134,000 - $149,000. 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

About Us

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.

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. 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.