About the position
The Associate Director, Global Regulatory Affairs is responsible for developing and executing regulatory strategy and plans for assigned projects within their region/country, ensuring timely, compliant submissions and approvals, and effective cross-functional collaboration. Key responsibilities include, but are not limited to the following; Define and execute regional regulatory strategy and plan for designated oncology programs. Lead in-region regulatory submissions, lifecycle management, and maintenance of approvals. Manage interactions with regional health authorities and coordinate responses to agency queries. Collaborate with global/regional teams to align regulatory activities with program timelines and milestones. Ensure compliance with regional regulatory requirements, internal standards, and governance processes. Mentor and influence cross-functional team members within the region; promote regulatory excellence. Monitor evolving regional regulations and guidelines to anticipate impact on programs. Support labeling negotiations, post-approval commitments, and pharmacovigilance activities as needed. Contribute to risk assessment and mitigation planning across the regulatory spectrum.
Responsibilities
• Define and execute regional regulatory strategy and plan for designated oncology programs.
• Lead in-region regulatory submissions, lifecycle management, and maintenance of approvals.
• Manage interactions with regional health authorities and coordinate responses to agency queries.
• Collaborate with global/regional teams to align regulatory activities with program timelines and milestones.
• Ensure compliance with regional regulatory requirements, internal standards, and governance processes.
• Mentor and influence cross-functional team members within the region; promote regulatory excellence.
• Monitor evolving regional regulations and guidelines to anticipate impact on programs.
• Support labeling negotiations, post-approval commitments, and pharmacovigilance activities as needed.
• Contribute to risk assessment and mitigation planning across the regulatory spectrum.
Requirements
• Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
• At least 5 years of experience in drug development and/or regulatory affairs, preferably Oncology.
• Demonstrated ability to lead in a matrixed environment and coordinate multi-disciplinary teams.
• Strong written and spoken English; proficiency in additional languages is a plus.
Nice-to-haves
• Strategic thinker with practical execution capabilities.
• Excellent stakeholder management, negotiation, and influencing skills.
• Ability to balance multiple priorities and manage regulatory risk.
• Experience with regional submissions and lifecycle management in one or more of the following regions: US, EU (Germany/France), or IRL.
• Customer-focus and commitment to scientific rigor.
Benefits
• health insurance
• paid time off (PTO)
• retirement contributions
• other perquisites