Job Title

Job ID :- 9f88ead3-0f06-41dd-8139-94f938c6a190ResponsibilitiesAs part of the Global Regulatory Affairs Oncology team, directly manage and provide leadership and mentorship to a team of regulatory representatives (GRT) responsible for the assigned products.As an active member, participate in multi-disciplinary teams in order to define the development and regulatory strategies of assigned early, mid-and late-stage development programs.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.Liaise with Health Authorities to negotiate Stemlineu2019s regulatory strategy for alignment, as well as for all routine regulatory submissions and correspondence.Identifies and communicates potential risks associated with different strategic scenarios.Identifies regulatory requirements and trends across therapeutic area of responsibility and provides regulators guidance and expertise to global development team and/or higher governance in this area.Presents global regulatory strategies to senior management as applicable.Contributes to the development of the Target Product Profile in collaboration with other functional areas.Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.Leads the development of regulatory information across assigned products, covering clinical development, labelling, protocols, reports, presentations, and other documents (internal and external).Leads the strategy regarding the preparation, review, and submission of health authority documents as required, including investigational and marketing applications, responses to Health Authority requests, meeting requests, briefing packages, annual reports, etc.Ensures consistency/completeness/accuracy and adherence to regulations and applicable guidelines for all regulatory submissions.Manages submission plans and timelines to ensure approvals and development objectives are timely met.Leads the global/regional regulatory team and represents the region as needed in project teams providing regulatory expertise for assigned projects.May participate in regulatory review of potential in-licensing opportunities/participation in regulatory due diligence activities.Mentor and support development of regulatory colleagues within the department.At Senior Director level, will also be responsible for: Global Strategy Lead for regulatory implementation.May be the primary RA representative and responsible to their region in relation to overall project strategy including pre-clinical and clinical (working with local RA where required).Responsible for the Global regulatory strategy and ensuring alignment with Global commercial plans and priorities to optimize portfolio.Designs, coordinates, directs, and conducts all global regulatory interactions, including United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) interactions and other competent health authorities.Responsible for regulatory interactions, and submissions, with strategic accountability for the regional filings while leveraging their GRT subject matter experts and endorsed by GRT.Trains, acts as mentor and ensures proactive communication and knowledge sharing of strategic regulatory topics with GRT and other relevant stakeholders.Acts as subject matter expert, as applicable.Challenges and improves existing procedures.Reviews relevant documents that will be included in regional /global regulatory applications/interactions in accordance with local and global regulatory guidance/legislation, as applicable, while leveraging GRT subject matter expertise.Manages coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAS/BLAs) for their region, working in a global collaborative manner. Ensures timely follow up and execution according to agreed timelines.Maintains expert knowledge of region and ICH guidance and familiarity with FDA/EMA/key international market regulations including Competitor intelligence/landscape.QualificationsMinimum of 6 years of relevant Regulatory Affairs experience, with increasing responsibility demonstrated in previous roles (10+ years for Senior Director)Experience in an Oncology therapeutic area.Demonstrated Leadership skills in a complex matrix environment.Demonstrated people management skills.Proven track record of success bringing new oncology products to registration.Prior experience in leading teams in the development and execution submissions including INDs, CTAs, BLAs, NDAs, MAAs.Regulatory Lead and expert knowledge in or more major regions (US/EU preferred).Demonstrated experience in Japan/China/RoW.Exceptional interpersonal skills with the ability to work in a global environment, individually as well in multi-disciplinary team, and with external partners and regulators.Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate with key stakeholders.Proven ability to consistently deliver within defined timelines, cost, and quality standards.Direct experience of interfacing with relevant regulatory fortable working in a matrix environment to achieve team goals and desired outcomes.Experience managing relationships with contractors and CROs is preferred.EducationScience based B.S. with requisite experience and demonstrated capability.Advanced degree (M.S.,PhD, PharmD) preferredPreferred:Global Oncology Drug DevelopmentIND/CTA/NDA/BLA/MAA experience (Oncology)Regulatory risk assessmentDue diligencesPrecision medicine/CDxPeople Management 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 $185,000-$265,000. Menarini Stemline offers generous compensation and benefits packages, including Short- and Long-Term Incentive Programs, 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.Minimum Salary: 185000Maximum Salary: 265000Salary Unit: Yearly