Regulatory Operations Manager - Submissions & Publishing (Hybrid)

Location: 

Cherry Hill, NJ, US

 

The purpose of Idorsia is to discover, develop and bring more, innovative medicines to patients. We have more ideas; we see more opportunities and we want to help more patients.  In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

 

Headquartered near Basel, Switzerland, the US Commercial Operations & Clinical Development teams are based near Philadelphia, Pennsylvania.  Idorsia is committed to meet the changing needs of healthcare professionals, patients and their families.  The core of what we do is to bring creative solutions to the market based on our science and data.

 

The DRA (Drug Regulatory Affairs) Operations Manager will oversee and contribute to the compilation and submission of US FDA submissions (IND, NDA/sNDA and subsequent maintenance activities) in eCTD format using appropriate tools/systems and working in close collaboration with the US DRA Project Leader/Manager and US Regulatory Submissions Specialist.

 

This role is part of a global organization where the direct line manager resides in another country.  There are local regulatory operations peers and departmental regulatory leaders in the US that are close partners.  The position is a hybrid, work from home/office, position where the office is located in Cherry Hill, NJ.  There are times where the individual will be asked to be in office, however most of the working time will be spent at home.

 

Responsibilities include, but are not limited to:

 

  • Represent DRA on Clinical Trial Teams (CTTs) and interface between CTTs, DRA Project Leader/Manager, Therapeutic Areas, Clinical Development Operations, or other departments, as required, to provide regulatory operational input and ensure clinical trial-related submissions are made as required to the US FDA.
  • Understand and communicate health authority procedural guidelines, decisions, and actions, in relation to assigned projects.
  • Provide support to the US DRA Project Leader/Manager and liaise within/outside DRA to ensure that deliverables are met for assigned projects, including preparation of submission documents, where required.
  • Participate in submission planning and track submissions in line with company procedures.
  • Responsible for daily prioritization of assigned projects, communicating project-related activities and timelines to other US DRA members as needed, and escalating issues where necessary to the Head US DRA and/or Global Regulatory Operations Group Leader.
  • Support/carry out submission compilation as required, including e.g., conducting document level publishing, assigning metadata, defining locations within the eCTD modular structure (with guidance from authors where necessary), building XML backbone, assigning eCTD leaf titles and lifecycle operators in accordance with company procedures and FDA accepted standards.
  • Conduct quality control (QC) of own submissions and submissions prepared by other DRA Operations members.
  • Monitor eCTD submission environment and procedures, understand and communicate new/updated regulatory procedural guidelines related to electronic submissions and implement changes as required.
  • Evaluate vendors for appropriate systems/tools to support establishment of new technical capabilities for electronic publishing/submissions.
  • Assist with software validation, testing of new applications/releases and system implementation.
  • Provide training on eCTD publishing processes and requirements related to the preparation, publishing, and life-cycle management of electronic submissions.
  • Author, review and maintain Quality System documents related to the work of the DRA Operations Group/DRA.

 

Qualifications:

 

  • Bachelor’s degree required, preferably in a science-related discipline
  • 4 years' experience in regulatory affairs and/or clinical operations, working in a CRO or pharmaceutical company
  • Experience compiling and submitting eCTD sequences to the US FDA
  • Experience with ISIToolbox and eCTD publishing software e.g., Lorenz docuBridge
  • Excellent MS Office skills (Word, Excel, PowerPoint)
  • Ability to work independently and as a member of a team
  • Ability to work effectively within tight timelines and often under pressure, must have working flexibility based on submission deadlines
  • Attention to detail, ability to check one’s own work, reliability, and conscientiousness

 

At Idorsia, we harness the power of difference, authenticity and inclusion to achieve business success. We are committed to fostering respect, fairness and equal opportunities for all job applicants and all our employees.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

 

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you will be informed in greater detail in due course.

 

Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, please note that all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.