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