Regulatory Affairs CMC Specialist/Manager, GRAO

Regulatory Affairs CMC Specialist/Manager, GRAO

Remote work/hybrid from within Europe

Opportunity

The Regulatory Affairs (RA) CMC Specialist/Manager is a member of the Global Regulatory Affairs Oncology department. He/she will be a key contributor for the successful development of Stemline/Menarini's portfolio and responsible for assisting with the implementation of the regulatory strategies for the oncology pipeline.

The RA CMC Specialist/Manager will provide regulatory CMC support and oversight for assigned products. In this role, He/She will support the implementation of global regulatory strategies and registration CMC requirements for one or more products/regions.

The assigned programs may have a different level of complexity with more than one indication, formulation, or external business partner.

Key Responsibilities

• Planning, coordination and preparation of regulatory submissions to the Regulatory Agencies, supporting the Global Regulatory CMC Lead (or delegate) on assigned oncology products.
• Support the identification and assessment of regulatory risks associated with assigned project responsibilities and assist in defining strategies to mitigate risks.
• Track submission timelines.
• Track Health Authority Information Requests and participate in the development and submission of team responses.
• Represent regulatory CMC on project teams for assigned projects.
• Collaborates with Global/Regional and Local (country) counterparts to ensure global/regional regulatory CMC strategy is defined and executed upon for all projects within the area of responsibility.
• Secure alignment between regulatory functions within the Global Regulatory Team (GRT) and the quality functions as well.
• Interacts with teams and key stakeholders in multiple departments at all levels.
• Ability to efficiently interact with a variety of external contacts (including consultants/contractors, corporate partners and regulatory agency personnel).
• Provides the regulatory-CMC assessment of the quality changes during development (e.g. clinical trials) and post-approval phases, worldwide, in collaboration with Regional and Local (country) counterparts where applicable.
• Authors and/or reviews of health authority CMC documents as required, including investigational and marketing applications, responses to Health Authority requests, meeting requests, briefing packages, annual reports, post-approval variations etc, worldwide.
• Manage regulatory CMC data and information within systems.

Education/Qualification Requirements

• BA / BS / University degree required; Life / Health Sciences preferred.
• Preferred 3 years of Regulatory Affairs and/or relevant drug/biologic development experience.
• Experience with life cycle management.
• EU regulatory CMC experience; RoW regulatory CMC experience would be desirable.
• Experience in interpretation of regulations, guidelines and policy statements.
• Experience and knowledge in the preparation of Regulatory submissions and supportive amendments or supplements (CTAs/MAAs).
• Experience in an Oncology therapeutic area is highly desirable.
• Direct experience of interfacing with relevant regulatory authorities is a plus.
• Ability to work both independently with minimal direction and within project teams to attain group goals.
• Demonstrate excellent communication skills.
• Strong organisational skills, including the ability to prioritise workload.

Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees

Company

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.