Director / Senior Director, Regulatory Advertising and Promotion

Director / Senior Director, Regulatory Advertising and Promotion Join to apply for the Director / Senior Director, Regulatory Advertising and Promotion role at Menarini Stemline Director / Senior Director, Regulatory Advertising and Promotion Join to apply for the Director / Senior Director, Regulatory Advertising and Promotion role at Menarini Stemline Overview Director, Global Regulatory Affairs Advertising & Promotion Reports to Executive Director, Global Labeling, Regulatory Operations and Advertising & Promotion 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. Overview Director, Global Regulatory Affairs Advertising & Promotion Reports to Executive Director, Global Labeling, Regulatory Operations and Advertising & Promotion 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. The Director of Regulatory Advertising and Promotion is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications for Stemline product(s) and / or development program(s). The Director serves as the company subject matter expert for the regulatory review of advertising and promotion materials and provides regulatory leadership to the respective cross-functional Legal, Medical, and Regulatory teams to ensure all communications, advertising and promotional materials and programs throughout product life cycle are compliant with applicable laws, regulations, and Company policies. Success in this role will require a thorough and current understanding of applicable Health Authority codes, laws, regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs and investigational treatments. 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. Responsibilities Provides strategic regulatory advice on promotional materials and activities related to Stemline brands in accordance with business objectives, company policy, and FDA Guidances and regulations. Provides specialized knowledge on region / country regulations and requirements governing product promotion and related communications, including pipeline and disease state communications. Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the pharmaceutical / biologics industry. Communicates significant changes in FDA perspective to relevant stakeholders. Serves as regulatory reviewer for assigned product(s) on Promotional Review Committee (PRC). As a regulatory reviewer, assesses the regulatory context and provide regulatory interpretations of applicable guidance and / or regulations or regulatory precedents, including requirements related to submission of material to Health Authority (HA) and interact with HA, as applicable. In conjunction with US RA department leadership team; proactively identifies and designs improvement opportunities to reduce compliance risk and increase efficiency and effectiveness in Regulatory Affairs. Participate in development, implementation and maintenance of regulatory policies and procedures. Provides direction and works collaboratively to ensure that changes in product labeling are carried into promotional materials in accordance with company procedures and regulatory requirements . Collaborates in cross-functional efforts to develop and update procedures and guidelines related to PRC processes. Creates and / or maintains Important Safety Information (ISI) for HCPs, consumers, and public relations. Plans and conducts training sessions as needed with stakeholders. Coordinates the development and implementation of regulatory strategies for promotion and advertising plans and is a leader in the Medical, Legal and Regulatory Review process to support approval and dissemination of marketed product and disease state promotional material. Reviews external communications materials, sales and marketing materials, including training, for compliance with current regulations and guidance. Participates in training for sales and marketing on advertising and promotional material. Represents the company to outside customers and agencies and makes presentations as needed on current regulatory issues pertaining to advertising and promotional activities. Sets clear objectives and consistently delivers while demonstrating full accountability for functional area results. Assist the Regulatory Leadership Team with financial and budgeting support for annual and long-range planning. Provide expertise while participating in assigned corporate leadership initiatives in various aspects of business process improvement. Qualifications Bachelor's degree in life sciences, pharmacy, or related field. Advanced degree preferred. Minimum of 10 years of experience in regulatory affairs, with at least 5 years in advertising and promotion compliance Expert knowledge of US laws, regulations, and guidance documents related to pharmaceutical advertising and promotion. Familiarity with global regulations and standards is a plus. Experience communicating and negotiating directly with OPDP and performing risk assessment. In-depth understanding of clinical study design and statistical analyses in assessment of promotional claims Ability to assess & communicate risk / benefit to senior management and influence organizational direction as it pertains to compliant advertising and promotion materials. Demonstrated problem solving abilities and conflict resolution skills. Excellent verbal and written organizational and communication skills; Experience influencing and communicating policy issues. Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization. Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and / or organizational goals. Must be detail-oriented, decisive, and capable of influencing individuals and managing teams while demonstrating leadership, flexibility, and strong communication skills. Menarini Stemline is 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 qualified individuals with disabilities to perform the essential functions Base Salary Range : $200,000-$280,000Seniority level Seniority levelDirector Employment type Employment typeFull-time Job function Job functionOther Referrals increase your chances of interviewing at Menarini Stemline by 2x Get notified about new Director / Senior Director, Regulatory Advertising and Promotion jobs in United States . 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Location: provincia-di-firenze, IT

Posted Date: 6/28/2025