Associate Director, Regulatory Operations

<span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><b><span style="font-family:Calibri, sans-serif;">Company Overview</span></b></span></span></span></span><br><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">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.</span></span></span></span></span><br><br><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><b><span style="font-family:Calibri, sans-serif;">Opportunity Overview</span></b></span></span></span></span><br><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">The Associate Director (AD) of Regulatory Operations is responsible for assisting the Head of Regulatory Operations in maintaining Rhythm&#8217;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.</span></span></span></span></span><br><br><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><b><span style="font-family:Calibri, sans-serif;">Responsibilities and Duties</span></b></span></span></span></span><ul><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">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</span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Identify/address opportunities to enhance operational effectiveness and drive process improvements within the department</span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Manage regulatory operations activities, including preparation of eCTD submission-ready documents, coordination across functions, and adherence to regulatory guidelines and processes </span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Support development program projects by collaborating with multi-disciplinary project teams to ensure successful program deliverables</span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Assist in the development of Standard Operating Procedures (SOPs) quality assurance, and records management practices related to regulatory operations activities</span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Track regulatory department information such as commitments with health authorities and NDA/IND commitments</span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Act as an expert resource for eCTD submissions to FDA, ensuring compliance with internal and health authority standards</span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Support the development and maintenance of operations resources for submission documents</span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Identify new or revised regulatory policies and initiate activities to support compliance</span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Participate in special projects and process improvement initiatives</span></span></span></span></span></li></ul><br><span style="font-size:11pt;"><span style="line-height:normal;"><span><span style="font-family:Aptos, sans-serif;"><b><span style="font-family:Calibri, sans-serif;">Qualifications and Skills</span></b></span></span></span></span><ul><li style="margin-left:8px;"><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Bachelor&#8217;s degree in life/physical sciences or related field</span></span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations</span></span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Knowledge and understanding of the drug development process</span></span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Strong knowledge of FDA and Global EU/UK regulations and guidelines, especially CTD and eCTD structure</span></span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Experience with Veeva RIM EDMS</span></span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Highly proficient in Microsoft Office suite</span></span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Ability to balance both strategic and operational approaches, &#8220;think outside the box&#8221; and to manage multiple tasks in a fast-paced environment</span></span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Detail-oriented and highly organized</span></span></span></span></span></span></li><li style="margin-left:8px;"><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">Excellent interpersonal skills and ability to develop collaborative partnerships with key stakeholders</span></span></span></span></span></span><br>&#160;</li></ul><span style="font-size:12pt;"><span style="background:#FFFFFF;"><span style="font-family:'Times New Roman', serif;"><i><span style="font-size:11pt;"><span style="background:#FFFFFF;"><span style="font-family:Calibri, sans-serif;"><span style="color:#0070c0;">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.</span></span></span></span></i><i><span style="font-size:11pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#0070c0;"> <span style="background:#FFFFFF;">This role may involve&#160;some travel.</span></span></span></span></i></span></span></span><br><br><i>The expected salary range for this position is $160,000 - $240,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.</i><br><br><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><b><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">More about Rhythm </span></span></i></b><br><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;"><span style="color:#000000;">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.</span></span></span></i><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">&#160; Our team is passionate about&#160;expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. </span></span></i></span></span></span><br><br><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">At Rhythm our core values are:</span></span></i></span></span></span><ul><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">We are committed to advancing scientific understanding to improve patients&#8217; lives</span></span></i></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">We are inspired to tackle tough challenges and have the courage to ask bold questions</span></span></i></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">We are eager to learn and adapt</span></span></i></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">We believe collaboration and ownership are foundational for our success</span></span></i></span></span></span></li><li style="margin-left:8px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">We value the unique contribution each individual brings to furthering our mission</span></span></i></span></span></span></li></ul><br><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">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. </span></span></i></span></span></span><br><br><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;">Headquartered in Boston, Rhythm is proud to have been named one of the </span></span></i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;"><a href="https://www.bostonglobe.com/magazine/top-places-work/2023/" style="color:#467886;text-decoration:underline;"><i>Top Places to Work</i></a><i> in Massachusetts.</i></span></span></span></span></span><br>&#160;