Senior Manager, Regulatory Affairs
Apply NowCompany: Alkermes
Location: Waltham, MA 02453
Description:
Job Description
The Senior Manager, Regulatory Operations will report to the Executive 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 Senior Manager, Regulatory Operations will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases.
Responsibilities:
Basic Qualifications:
Preferred Qualifications:
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.
The Senior Manager, Regulatory Operations will report to the Executive 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 Senior 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.
Basic Qualifications:
- At least 10 years of related experience, with at least 5-7 years of direct experience in Regulatory Operations
Preferred 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.
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.