Menarini Stemline
Director/Senior Director, Global Regulatory Affairs, Oncology
Menarini Stemline, New York, New York, us, 10261
Director/Senior Director, Global Regulatory Affairs, Oncology
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Menarini Stemline . Overview
The Director/Senior Director of Global Regulatory Affairs Oncology (Early Development and Lifecycle Strategy) is a leader in the Global Regulatory Affairs Oncology department and a key contributor to the successful development of Stemline/Menarini’s pipeline. The Director, as a Global Regulatory Lead (GRL), is responsible for implementing regulatory strategies for assigned products/projects and providing regulatory guidance and oversight to obtain optimal labeling and the shortest timing to approval by Regulatory Agencies. All regulatory activities are conducted with oncology patients in mind, keeping up-to-date with US/EU regulations, key Health Authority guidance, and regulatory precedents, and assessing opportunities for expedited development pathways/regulatory mechanisms. At the Senior Director level, the role is responsible for creating and driving the Global Regulatory strategy for products/projects and ensuring a robust regulatory foundation aligned with business priorities, working with local and regional stakeholders to ensure global strategy alignment. Responsibilities
Lead and mentor a team of regulatory representatives (GRT) responsible for assigned products. Participate in multi-disciplinary teams to define development and regulatory strategies for early, mid, and late-stage programs. Collaborate with Global/Regional and Local counterparts to define and execute global/regional regulatory strategy. Liaise with Health Authorities to negotiate regulatory strategy and for routine submissions and correspondence. Identify and communicate potential regulatory risks and requirements across therapeutic area, providing guidance to global development teams. Present global regulatory strategies to senior management as applicable. Contribute to Target Product Profile development with other functions. Support value and access discussions by partnering with access functions. Lead development of regulatory information across products, including clinical development, labeling, protocols, reports, and submissions. Lead preparation, review, and submission of health authority documents (INDs/CTAs, MAAs, NDAs/BLAs) and respond to Health Authority requests. Ensure consistency, completeness, accuracy, and compliance with regulations for all submissions. Manage submission plans and timelines to achieve approvals and development objectives. Lead the global/regional regulatory team and represent the region in project teams. Participate in regulatory due diligence for potential in-licensing opportunities as applicable. Mentor and support development of regulatory colleagues. At Senior Director Level, Will Also Be Responsible For
Global Strategy Lead for regulatory implementation. Primary RA representative for region, aligning project strategy with pre-clinical and clinical work (in collaboration with local RA as required). Global regulatory strategy aligned with Global commercial plans and portfolio optimization. Coordinate and conduct global regulatory interactions with FDA, EMA, and other authorities. Regulatory interactions and submissions with strategic regional filings leveraging GRT. Mentor, communicate, and share strategic regulatory topics with GRT and stakeholders. Act as subject matter expert and improve procedures. Review documents for regional/global regulatory applications/interactions in line with guidance and legislation, leveraging GRT expertise. Manage coordination, preparation, and timely submission of filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs) for their region in a global context. Maintain expert knowledge of ICH guidance and regulatory requirements in key markets. Qualifications
Minimum of 6 years of relevant Regulatory Affairs experience (10+ years for Senior Director). Experience in Oncology therapeutic area. Demonstrated leadership and people-management skills in a complex matrix environment. Proven track record of bringing oncology products to registration and leading submissions (INDs, CTAs, BLAs, NDAs, MAAs). Regulatory lead and expertise in US/EU (preferred) with experience in Japan/China/RoW. Excellent interpersonal skills and ability to work in global, cross-functional teams and with regulators and external partners. Ability to generate innovative regulatory solutions and deliver within timelines and budgets. Experience interfacing with regulatory authorities and managing relationships with contractors/CROs (preferred). Education
Science-based B.S. with relevant experience; advanced degree (M.S., PhD, PharmD) preferred. Preferred
Global Oncology Drug Development IND/CTA/NDA/BLA/MAA experience (Oncology) Regulatory risk assessment, due diligences, precision medicine/CDx People management The job is classified as a corporate office position. Salary range: Base $185,000-$265,000 with comprehensive compensation and benefits. All qualified applicants will receive consideration without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
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Join to apply for the Director/Senior Director, Global Regulatory Affairs, Oncology role at
Menarini Stemline . Overview
The Director/Senior Director of Global Regulatory Affairs Oncology (Early Development and Lifecycle Strategy) is a leader in the Global Regulatory Affairs Oncology department and a key contributor to the successful development of Stemline/Menarini’s pipeline. The Director, as a Global Regulatory Lead (GRL), is responsible for implementing regulatory strategies for assigned products/projects and providing regulatory guidance and oversight to obtain optimal labeling and the shortest timing to approval by Regulatory Agencies. All regulatory activities are conducted with oncology patients in mind, keeping up-to-date with US/EU regulations, key Health Authority guidance, and regulatory precedents, and assessing opportunities for expedited development pathways/regulatory mechanisms. At the Senior Director level, the role is responsible for creating and driving the Global Regulatory strategy for products/projects and ensuring a robust regulatory foundation aligned with business priorities, working with local and regional stakeholders to ensure global strategy alignment. Responsibilities
Lead and mentor a team of regulatory representatives (GRT) responsible for assigned products. Participate in multi-disciplinary teams to define development and regulatory strategies for early, mid, and late-stage programs. Collaborate with Global/Regional and Local counterparts to define and execute global/regional regulatory strategy. Liaise with Health Authorities to negotiate regulatory strategy and for routine submissions and correspondence. Identify and communicate potential regulatory risks and requirements across therapeutic area, providing guidance to global development teams. Present global regulatory strategies to senior management as applicable. Contribute to Target Product Profile development with other functions. Support value and access discussions by partnering with access functions. Lead development of regulatory information across products, including clinical development, labeling, protocols, reports, and submissions. Lead preparation, review, and submission of health authority documents (INDs/CTAs, MAAs, NDAs/BLAs) and respond to Health Authority requests. Ensure consistency, completeness, accuracy, and compliance with regulations for all submissions. Manage submission plans and timelines to achieve approvals and development objectives. Lead the global/regional regulatory team and represent the region in project teams. Participate in regulatory due diligence for potential in-licensing opportunities as applicable. Mentor and support development of regulatory colleagues. At Senior Director Level, Will Also Be Responsible For
Global Strategy Lead for regulatory implementation. Primary RA representative for region, aligning project strategy with pre-clinical and clinical work (in collaboration with local RA as required). Global regulatory strategy aligned with Global commercial plans and portfolio optimization. Coordinate and conduct global regulatory interactions with FDA, EMA, and other authorities. Regulatory interactions and submissions with strategic regional filings leveraging GRT. Mentor, communicate, and share strategic regulatory topics with GRT and stakeholders. Act as subject matter expert and improve procedures. Review documents for regional/global regulatory applications/interactions in line with guidance and legislation, leveraging GRT expertise. Manage coordination, preparation, and timely submission of filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs) for their region in a global context. Maintain expert knowledge of ICH guidance and regulatory requirements in key markets. Qualifications
Minimum of 6 years of relevant Regulatory Affairs experience (10+ years for Senior Director). Experience in Oncology therapeutic area. Demonstrated leadership and people-management skills in a complex matrix environment. Proven track record of bringing oncology products to registration and leading submissions (INDs, CTAs, BLAs, NDAs, MAAs). Regulatory lead and expertise in US/EU (preferred) with experience in Japan/China/RoW. Excellent interpersonal skills and ability to work in global, cross-functional teams and with regulators and external partners. Ability to generate innovative regulatory solutions and deliver within timelines and budgets. Experience interfacing with regulatory authorities and managing relationships with contractors/CROs (preferred). Education
Science-based B.S. with relevant experience; advanced degree (M.S., PhD, PharmD) preferred. Preferred
Global Oncology Drug Development IND/CTA/NDA/BLA/MAA experience (Oncology) Regulatory risk assessment, due diligences, precision medicine/CDx People management The job is classified as a corporate office position. Salary range: Base $185,000-$265,000 with comprehensive compensation and benefits. All qualified applicants will receive consideration without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
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