Global Regulatory Submission Management Specialist

Boston, MA
Full Time
Regulatory Affairs
Entry Level
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.  The position reports into the Director, Global Regulatory Affairs.

Responsibilities and Duties
Submission & Project 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.
Regulatory Department Support
  • Maintains trackers for regulatory team, 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.

Qualifications and Skills
  • 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 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

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel. 

More about Rhythm
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

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.
Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.
 
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