Manager/Senior Manager, Global Regulatory Affairs

Overview

The Manager/Senior Manager of Global Regulatory Affairs Oncology 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 pipeline and responsible for assisting with the implementation of the regulatory strategies for the oncology portfolio. He/She will work with the Global Regulatory Lead, to provide overall regulatory guidance and oversight for all assigned products to obtain the optimal label and the shortest timing to approval by Regulatory Agencies. In this role, he/she will implement the global regulatory strategies and registration 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. The position holder will be part of an international environment and will contribute to developing the network and expanding the knowledge of the GRA Oncology team.

Responsibilities

• Support the preparation, review, and submission of health authority documents as required, including marketing applications, responses to Agencies’ questions and requests, meeting requests, briefing packages, annual reports, etc. Represents GRA as a team member and provides relevant regulatory strategy into clinical, labelling, protocols, reports, presentations, and other documents.
• Coordinate the preparation, review and submission including responses to Agencies’ questions and requests, meeting requests, briefing packages, annual reports, etc.
• Identify and assess regulatory risks associated with assigned project responsibilities and assist in defining strategies to mitigate risks.
• Assist GRL in building and maintaining relationships with relevant regulatory agencies, contractors and corporate partners.
• Coordinate the preparation, review and submission of marketing applications.
• Ensure consistency/completeness/accuracy and adherence to regulations and applicable guidelines for all regulatory submissions.
• Manage submission plans and timelines to ensure approvals and development objectives are timely met.
• Review and analyse competitors’ information, recent product approvals local public Advisory Committee proceedings and global Agencies’ guidelines, to support the development of strong regulatory strategies.
• Contribute to the development of the Target Product Profile in collaboration with various line functions.
• Interacts with key stakeholders in multiple departments at all levels.
• Collaborates with Global/Regional and Local (country) counterparts to ensure global/regional regulatory strategy is defined and executed upon for all projects within area of responsibility.
• Document regulatory contacts with Health Authorities.
• Manage regulatory data and information within systems.

Qualifications

Skills/Qualifications:

• BA / BS / University degree required; Life / Health Sciences preferred.
• 2-4 years of Regulatory Affairs and relevant drug/biologic development experience.
• EU/US regulatory experience preferred, including track record of managing submissions.
• Experience in an Oncology therapeutic area is highly desirable.
• Prior experience in managing and submitting INDs, CTAs, BLA, NDAs, MAAs and life cycle management.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate with key stakeholders.
• Knowledge of regulations, guidelines and policy statements.
• Proven ability to consistently deliver within defined timelines, cost, and quality standards.
• Excellent interpersonal skills with the ability to work in a global environment, individually as well as in a multi-disciplinary team, and with external partners and Regulators.
• Ability to represent the department in project teams.
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Knowledge and understanding of applicable regulations.
• RoW regulatory experience is desirable.
• Direct experience of interfacing with relevant regulatory authorities is a plus.
• Experience managing relationships with contractors and CROs also preferred. 

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. 

Base Salary Range of $135,000-$180,000. Menarini Stemline offers generous compensation and benefits packages, including Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs. 

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.

The 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. 

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.