Associate Director, Regulatory Operations, Boston

Associate Director, Regulatory Operations

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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
The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory Operations in maintaining Rhythm's regulatory submission standards and current electronic submission guidelines/requirements. This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines. Additionally, the Associate Director supports the preparation and submission of Investigational New Drug applications (INDs), New Drug applications (NDAs), annual reports, Development Safety Update Reports (DSURs), and safety reports to regulatory authorities.

Responsibilities and Duties

Manage regulatory operations activities, ensuring timely and accurate regulatory submissions, and collaborating with cross-functional teams for our US, EU, UK and Health Canada regions
Identify/address opportunities to enhance operational effectiveness and drive process improvements within the department
Manage regulatory operations activities, including preparation of eCTD submission-ready documents, coordination across functions, and adherence to regulatory guidelines and processes
Support development program projects by collaborating with multi-disciplinary project teams to ensure successful program deliverables
Assist in the development of Standard Operating Procedures (SOPs) quality assurance, and records management practices related to regulatory operations activities
Track regulatory department information such as commitments with health authorities and NDA/IND commitments
Act as an expert resource for eCTD submissions to FDA, ensuring compliance with internal and health authority standards
Support the development and maintenance of operations resources for submission documents
Identify new or revised regulatory policies and initiate activities to support compliance
Participate in special projects and process improvement initiatives

Qualifications and Skills

Bachelor's degree in life/physical sciences or related field
8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations
Knowledge and understanding of the drug development process
Strong knowledge of FDA and Global EU/UK regulations and guidelines, especially CTD and eCTD structure
Experience with Veeva RIM EDMS
Highly proficient in Microsoft Office suite
Ability to balance both strategic and operational approaches, "think outside the box" and to manage multiple tasks in a fast-paced environment
Detail-oriented and highly organized
Excellent interpersonal skills and ability to develop collaborative partnerships with key stakeholders

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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Location:: Boston

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