Regulatory Submission and Project Management Specialist

<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;">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.&#160; The position reports into the Global Regulatory Lead for one or more programs. </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><br><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Submission &amp; Project Management</span></span></span></span><ul><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">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.</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">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.</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">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.</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Proactively communicates issues or delays related to the completion of planned submissions.</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Liaises with cross-functional collaborators to gain alignment and ensure that submission requirements and timelines are understood.</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Effectively manages multiple projects and competing priorities.</span></span></span></span></li></ul><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Regulatory Department Support</span></span></span></span><ul><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Maintains regulatory trackers for assigned programs, including submission calendar, archives of regulatory submissions, correspondence and commitments.</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">May assist in management of special projects as needed (e.g., oversight of system/process improvement projects).</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Assist with regulatory inspection readiness activities.</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:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Bachelor's degree preferred, scientific and/or computer science field preferred</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">At least 1 year of relevant pharmaceutical experience (or relevant internship experience within a graduate-level degree program)</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Requires eCTD knowledge</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">RAC certification desirable</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Knowledge of Veeva RIM Suite preferred</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Experience with StartingPoint templates preferred</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Working knowledge of the drug development process</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Solid understanding of regulatory requirements and submission processes</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Excellent collaboration and time management skills; ability to handle multiple work assignments concurrently; ability to coordinate and prioritize conflicting deadlines</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Strong organizational skills with detail-oriented focus</span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">A demonstrated ability to work with minimal supervision </span></span></span></span></li><li style="margin-left:32px;"><span style="font-size:11pt;"><span style="line-height:normal;"><span style="font-family:Aptos, sans-serif;"><span style="font-family:Calibri, sans-serif;">Excellent verbal and written communication skills</span></span></span></span></li></ul><br><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><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;">The expected salary range for this position is $72,000 - $108,000. 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.</span></span></span></span></i></span></span></span><br><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="text-align:justify;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="text-align:justify;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="text-align:justify;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="text-align:justify;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="text-align:justify;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-family:Calibri, sans-serif;"><a href="https://www.bostonglobe.com/magazine/top-places-work/2023/" style="color:#467886;text-decoration:underline;"><i><span style="font-size:10pt;">Top Places to Work</span></i></a></span><i><span style="font-size:10pt;"><span style="font-family:Calibri, sans-serif;"> in Massachusetts.</span></span></i></span></span></span>