Manager, Regulatory Operations

Overview

Job title: Manager, Regulatory Operations

Reports to Manager Job Title: Director, Regulatory Operations

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group's headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.

Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini's oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).

Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.

Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.

Menarini's commitment to oncology is also reflected in the investments made in the liquid biopsy diagnostic field through its affiliate Menarini Silicon Biosystems (MSB), a pioneer in rare cell analysis and non-invasive, advanced diagnostic solutions. MSB's CELLSEARCH Circulating Tumour Cell (CTC) Test is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs in metastatic breast, prostate, and colorectal cancer when used in conjunction with other clinical monitoring methods.

Since 2021, MSB has offered in the US a menu of non-invasive Laboratory Developed Tests (LDTs) provided through its CLIA/CAP accredited US-based Lab. The services include CMC enumeration, CTC enumeration and PDL-1/HER2 biomarker and offer a minimally invasive approach to follow cancer patient's therapeutic journey.

In 2022, the company launched the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Enumeration LDT, the first-of-its-kind, which directly measures levels of plasma cells in the blood of patients. This test provides new, complementary information to that of the bone marrow biopsy and other standard-of-care measures. Due to its minimally invasive nature, it can be performed serially to assess plasma cell burden without requiring repeated bone marrow biopsies.

Menarini's vision and uniqueness in oncology is to bring together innovative therapeutic solutions and advanced liquid biopsy-based diagnostics for faster, more effective and precise patient management.

It is an exciting time in the company's development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline's Oncology business.

Responsibilities

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. Qualifications

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.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.