Senior Associate, Global Regulatory Strategy for Oncology

Role Summary

In this role, you will:

• Provide strategic product direction and interact with regulatory agencies to expedite the approval of pending registrations
• Serve as the regulatory liaison throughout the product lifecycle, representing regulatory interests to marketing, research project teams, and government agencies
• Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports
• Guide operational teams in managing projects, preparing resource forecasts, and identifying areas for improvement in products, processes, or services
• Lead or co-lead moderately complex projects, managing time and resources effectively, and provide guidance to teams
• Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems
• Work independently, receive instruction on unusual or complex problems, and determine objectives of assignments
• Review own work, seek directional review from others, and mentor colleagues by reviewing their work
• Collaborate with Global Chemistry Manufacturing and Controls and other key stakeholders to ensure well-defined and executed filing strategies for initial registrations and lifecycle submissions
• Enhance efficiencies in regulatory submissions and processes by working across the organization with various stakeholders

Qualifications

• Bachelors degree with at least 2 years of experience
• Effective delivery in a complex matrix environment
• Regulatory experience, including knowledge of New Drug Application (NDA) and Investigational New Drug (IND) submission processes
• In-depth understanding of national and regional regulatory legislation and guidelines
• Proficiency in pharmaceutical analytics technology, pharmacology, toxicology, and medicine
• Leadership qualities and management skills
• Strong written and verbal communication and interpersonal skills

Preferred Qualifications

• Master's degree is highly desirable, coupled with relevant experience in the pharmaceutical industry
• Background in pharmaceuticals, providing a solid foundation for the role
• Experience in the pharmaceutical sector, enhancing the ability to contribute effectively
• Advanced education and practical experience, ensuring a well-rounded and capable professional