Job Description

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that\xe2\x80\x99s passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway diseases. 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 Regulatory Operations Manager will lead in the preparation and submission of electronic regulatory documents through the FDA, EMA, MHRA, and Health Canada Electronic Submission Gateways (ESG,), as well as prepare and file non-eCTD submissions, to ensure compliance with applicable laws and regulations. The scope of this role includes formatting and publishing regulatory documents, managing document tracking and version control, archiving on- and off-site, maintaining a thorough understanding of US and Global regulatory requirements, collaborating with cross-functional teams, and identifying opportunities for process improvements. In addition to these standard publishing requirements, the Regulatory Operations Manager will bring project management skills and technical experience in document management and publishing systems to this role.

Responsibilities and Duties

• Lead in the preparation and submittal of regulatory applications and on-going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (e.g., IND, NDA and MAA,). Participate in project-planning meetings to provide input on submission timelines in collaboration with Manager, Regulatory Operations.
• Ensure consistency across regulatory submission documents following the regulatory style guide (i.e. formatting, reviewing, and submissions).
• Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents.
• Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements, as well as ensure metadata is correctly applied.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submission documents/correspondences.
• Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives while continuing to stay well-informed on future developments.
• Actively participate in the development of Regulatory Operations processes (SOPs/GOPs, work instructions, checklist, templates) for preparing submissions and regulatory information management, in addition to assisting in the creation and maintenance of templates.
• Work with Veeva RIM BA(s), subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions and Submissions Archive)
• Support global partnerships across the organization to help implement Regulatory Operations\xe2\x80\x99 initiatives by attending and participating in Project Teams if deemed appropriate by manager.
• Maintain knowledge of local and global regulatory submission requirements.
• Ensure adherence to Company Standard Operating Procedures.
• Other duties as assigned.

Qualifications and Skills

• BS/BA in scientific discipline preferred, advanced degree is a plus.
• 5 + years of related experience, with at least 2 years in a pharmaceutical environment.
• Proven experience in preparing and submitting global regulatory documents, including nonclinical, clinical, CMC, and labeling/SPL, in eCTD format
• Thorough knowledge and understanding of relevant FDA guidance, ICH guidelines and other regulatory requirements
• Proficiency in using:

• Software and tools for document formatting, publishing, submissions, and tracking (i.e. MS Office, Acrobat Adobe, ISI Toolbox, and at least one eCTD publishing system)
• Veeva Vault RIM, ESG Gateway, Syncplicity (EMA Gateway), and MHRA Portal

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

Rhythm is a global, commercial-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm\xe2\x80\x99s mission is to improve the understanding of these diseases and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company\xe2\x80\x99s clinical development program is currently focused on several rare MC4R pathway diseases. For healthcare professionals, visit www.RareObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.

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Rhythm Pharmaceuticals