• Partner with and mentor the Regulatory Affairs Directors aligning on global innovative regulatory strategies for products.
• Provide critical review and input on disease area and portfolio regulatory strategies, risk planning and mitigations.
• Effectively represent the Global Regulatory Affairs function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.
• Collaborate with regional policy and intelligence groups to critically analyse the assessment of emerging science, data and changes in the regulatory environment and advise senior management on project risks/mitigation activities accordingly.
• Define and drive disease area global regulatory policies and priorities.
• Lead budget management, resource planning and recruitment of staff.
• Review and approve high-level documents for global regulatory submissions as well as core prescribing information.
• Ensure submission excellence framework is timely and consistently applied across projects including sharing the best submission practises and knowledge and using existing tools.

• Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
• Previous demonstrated drug development experience.
• Oncology therapy area knowledge/experience.
• Experience in global regulatory strategy and submissions that have progressed through to registration.
• Significant experience in leading major health Authority interactions
• Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
• Experience in managing people both directly and in a matrixed organisational structure.
• Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities.
• Ability to travel domestically and internationally.

Preferred:

• Advanced degree in a scientific subject area (e.g. MSc, PhD, PharmD, MD)