Associate Director, Regulatory Operations
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
- 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
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
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