Regulatory Submission and Project Management Specialist
Rhythm Pharmaceuticals
Boston, MA
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
In support of our continued growth, we are looking for a Global Regulatory Submission Management Specialist to join our Global Regulatory Team. This is a highly visible role with excellent career development opportunities within Global Regulatory Affairs for motivated candidates. The position reports into the Global Regulatory Lead for one or more programs. Responsibilities and Duties
Submission & Project Management
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
In support of our continued growth, we are looking for a Global Regulatory Submission Management Specialist to join our Global Regulatory Team. This is a highly visible role with excellent career development opportunities within Global Regulatory Affairs for motivated candidates. The position reports into the Global Regulatory Lead for one or more programs. Responsibilities and Duties
Submission & Project Management
- Responsible for management of asset-level global regulatory submission planning including annual reporting and ad hoc submissions for both development programs and post-approval life cycle management.
- Responsible for the planning and tracking of routine and ad hoc US, EU, and Global regulatory submissions, monitoring the submission forecast and ensuring high quality, compliant and validated submissions to health authorities within required timelines.
- Manages submission calendar, creates content plans for lifecycle and global submissions across multiple global applications, creates timelines and oversees responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date.
- Proactively communicates issues or delays related to the completion of planned submissions.
- Liaises with cross-functional collaborators to gain alignment and ensure that submission requirements and timelines are understood.
- Effectively manages multiple projects and competing priorities.
- Maintains regulatory trackers for assigned programs, including submission calendar, archives of regulatory submissions, correspondence and commitments.
- May assist in management of special projects as needed (e.g., oversight of system/process improvement projects).
- Assist with regulatory inspection readiness activities.
- Bachelor's degree preferred, scientific and/or computer science field preferred
- At least 1 year of relevant pharmaceutical experience (or relevant internship experience within a graduate-level degree program)
- Requires eCTD knowledge
- RAC certification desirable
- Knowledge of Veeva RIM Suite preferred
- Experience with StartingPoint templates preferred
- Working knowledge of the drug development process
- Solid understanding of regulatory requirements and submission processes
- Excellent collaboration and time management skills; ability to handle multiple work assignments concurrently; ability to coordinate and prioritize conflicting deadlines
- Strong organizational skills with detail-oriented focus
- A demonstrated ability to work with minimal supervision
- Excellent verbal and written communication skills
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Posted 2026-01-23
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