Alkermes
Associate Director, Regulatory Affairs Operations
Alkermes, Waltham, Massachusetts, United States, 02254
Job Description
The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands‑on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases.
You’ll work closely with Regulatory Affairs and cross‑functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization.
Key Responsibilities
Lead end‑to‑end management of regulatory submissions, ensuring timely, compliant, and high‑quality deliverables.
This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities.
Serve as submission manager and primary contact for publishing vendors and internal stakeholders.
Oversee regulatory document management, tracking, and archival activities.
Manage regulatory systems (e.g., Veeva RIM, PromoMats), and serve as internal subject matter expert (SME) for training and support to internal stakeholders.
Develop and implement processes, templates, and tools that improve submission efficiency and consistency.
Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases.
Provide subject matter expertise on regulatory technologies and submission best practices.
Monitor new regulations and industry trends to assess impact on operational practices.
Basic Qualifications
Bachelor’s degree in a scientific or related field.
At least 10 years of related experience, with at least 8 years of regulatory operations experience in the biotech or pharmaceutical industry.
Preferred Qualifications
Strong understanding of eCTD submission standards and regulatory requirements across global regions.
Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management.
Hands‑on experience with Veeva RIM and/or PromoMats strongly preferred.
Experience managing outsourced publishing vendors a plus.
Skilled at balancing strategic oversight with hands‑on execution.
Strong communicator and collaborator with excellent organizational skills.
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.
#J-18808-Ljbffr
You’ll work closely with Regulatory Affairs and cross‑functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization.
Key Responsibilities
Lead end‑to‑end management of regulatory submissions, ensuring timely, compliant, and high‑quality deliverables.
This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities.
Serve as submission manager and primary contact for publishing vendors and internal stakeholders.
Oversee regulatory document management, tracking, and archival activities.
Manage regulatory systems (e.g., Veeva RIM, PromoMats), and serve as internal subject matter expert (SME) for training and support to internal stakeholders.
Develop and implement processes, templates, and tools that improve submission efficiency and consistency.
Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases.
Provide subject matter expertise on regulatory technologies and submission best practices.
Monitor new regulations and industry trends to assess impact on operational practices.
Basic Qualifications
Bachelor’s degree in a scientific or related field.
At least 10 years of related experience, with at least 8 years of regulatory operations experience in the biotech or pharmaceutical industry.
Preferred Qualifications
Strong understanding of eCTD submission standards and regulatory requirements across global regions.
Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management.
Hands‑on experience with Veeva RIM and/or PromoMats strongly preferred.
Experience managing outsourced publishing vendors a plus.
Skilled at balancing strategic oversight with hands‑on execution.
Strong communicator and collaborator with excellent organizational skills.
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.
#J-18808-Ljbffr