Regulatory Submissions Specialist US (Remote)

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 Regulatory Submissions Specialist will be responsible for the compilation and submission of Food & Drug Administration (FDA) submissions such as IND, NDA/sNDA and subsequent maintenance activities in eCTD format using appropriate tools and systems.  

This position will report to a direct line manager located at Idorsia’s headquarters in Switzerland, however, day to day responsibilities and interactions will focus on the US-based Drug Regulatory Affairs (DRA) team, its Operations and Project Leaders.  This role requires a great deal of collaboration, deadline management, accuracy & detail.

This position is fully remote but the successful candidate must reside in either the US eastern or central time zones.  Up to 5% travel can be expected both within the US and internationally.

Responsibilities include, but are not limited to:

• Compilation and submission of FDA submissions, including IND, NDA/sNDA and subsequent maintenance activities in the eCTD format using appropriate tools and systems.
• Verify and ensure accuracy of all submission documents and carry out electronic publishing to current eCTD standards.
• Submission compilation, including e.g., assigning metadata, defining locations within the eCTD structure (with guidance from document 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 (content and backbone structure), both manually and using appropriate validation software in accordance with company procedures and FDA accepted standards. 

• Manage assigned eCTD submissions through the Electronic Submissions Gateway (ESG), including troubleshooting any technical issues.
• Provide input to submission timelines and track submissions in line with company procedures.
• Provide Electronic Document Management System (EDMS) user support for Idorsia US team members.
• Author, review and maintain Quality System documents.
• Monitor eCTD submission environment and procedures, understand and communicate new/updated regulatory procedural guidelines related to electronic submissions and implement changes as required.
• Provide training on eCTD publishing processes and requirements related to the preparation, publishing and life-cycle management of electronic submissions

Qualifications:

• Bachelor's degree required
• 2 years of US regulatory experience with electronic submission publishing in eCTD format to the FDA required
• Experience with docuBridge and Veeva Vault RIM required
• Excellent Word and Adobe Acrobat skills required
• Committed attention to detail; accurate and meticulous required
• Ability to work independently and under pressure (able to prioritize tasks, deadline-oriented, good organizational and problem-solving skills) required

• Excellent customer service skills required
• Ability to communicate effectively (spoken and written) required

• Experience of working effectively in a global environment preferred
• Experience of working effectively in a matrix environment preferred
• Knowledge of XML preferred
• Knowledge of ISIToolbox preferred

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.