Job title: Manager, Regulatory Operations

Reports to: Director, Regulatory Operations

Opportunity

The Manager of Regulatory Operations coordinates and actively participates in Regulatory submission publishing activities within the Regulatory Operations department.

Is responsible for successfully leading, directing, and monitoring the daily activities required in the execution of global marketing application submissions, process improvement, and transition projects from planned development through completion for assigned projects.

Success in this role will require a thorough and current understanding of appropriate eCTD FDA and ICH regulations pertaining to global regulatory and technical requirements for documents of all submission dossier types, including Word document format, PDF specifications, and CTD structure, with full awareness of a global environment, and a robust knowledge of regulatory information management systems.

Responsibilities

• Demonstrate strong leadership and accountability for assigned projects with a proven understanding of IND, CTA, BLA, and MAA submissions in eCTD format including but not limited to: initial applications, post-marketing commitments, and lifecycle management activities.
• Demonstrate leadership and expertise in all aspects of formatting, publishing, version control, and quality control of Word and PDF documents with full knowledge of global document specifications per ICH and FDA guidance.
• Compile, publish, and verify submission dossiers in accordance with international eCTD requirements.
• Review hypertext links, ensure PDFs are submission ready, potentially format tables and graphics, bookmark sections, and proof submissions according to internal standards.
• Is responsible for submission planning, timelines, document preparation, global submission activities, providing vendor oversight for outsourced activities and archival processes.
• Lead the development of IND, NDA, BLA and MAA publishing content plans and track document deliverables to meet submission deadlines.
• Works through complex situations across functional areas and identifies issues that may delay timelines while recommending appropriate action through strategic decisions and recommendations.
• Liaise with external publishing vendor to transmit IND, BLA, NDA eCTD submissions to the FDA via the ESG.
• Author job aids with illustrating tasks and processes associated with document approvals, workflows, searching, archiving, commitments, running reports, when needed.
• Submission tracking, metrics, and reporting when needed.

Skills/Knowledge

• Bachelor’s and/or master’s degree in a scientific, technical, or related discipline with a minimum of 5-7 years relevant experience in Regulatory Operations and project management.
• Prior experience with IND, CTA, BLA, MAA marketing applications, lifecycle management, and postmarking submissions.
• Demonstrated knowledge of current CTD/eCTD format and regulatory submission requirements.
• Experience compiling/publishing global eCTD submissions
• Extensive experience with Microsoft Word and Adobe Acrobat (experience with StartingPoint templates and DXC Toolbox preferred).
• Experience using Regulatory Information Management System (RIM) (Veeva RIM experience preferred).
• Working knowledge of publishing tools (e.g., Lorenz Docubridge Veeva), global submission validation tools, HA electronic submission gateways,
• Must have superior quality control document review skills for Word and PDF with the ability to identify, communicate, and train on inconsistencies that align with Menarini Stemline processes.
• Ability to multitask and successfully tracking and multiple submission deliverables across several products is essential for success in this role.
• Must be detail-oriented, decisive, and capable of influencing individuals and managing eCTD submission compilation while demonstrating leadership, flexibility, and strong communication skills

Please note--this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Menarini Stemline is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.