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Global Regulatory Affairs Lead
hace 2 meses
Key Responsibilities:
- Serve as the single point of contact and accountability within the Global Regulatory Affairs team for assigned programs, collaborating closely with the Core Asset Team and Medicines Development Team.
- Chair the Global Regulatory Team, comprising regulatory subject matter experts, to provide strategic guidance and oversight for assigned programs.
- Develop and implement global regulatory strategies, including risk assessment and mitigation, to ensure timely and compliant access to rare disease therapies.
- Represent Sobi at major regulatory agency meetings, such as the US FDA, EMA/CHMP, PMDA, and NMPA/CDE, to advocate for patients' interests and advance regulatory approvals.
- Present to senior leadership on assigned program progress and regulatory strategies, ensuring alignment with business objectives.
- Collaborate with cross-functional teams, including Commercial, Pharmacovigilance & Patient Safety, Supply Chain, Quality, Manufacturing & Supply, Clinical Development, and Global Medical & Scientific Affairs, to drive regulatory excellence.
- Participate in strategic evaluations of in-licensing opportunities and provide regulatory input to inform business decisions.
- May have direct oversight and management of Regulatory Affairs team members supporting assigned programs, ensuring effective team performance and regulatory compliance.
- Exercise authority to approve services and costs within budget, in accordance with Sobi's delegation of authority.
- Review and update regulatory standard operating procedures as needed to ensure alignment with changing regulatory requirements.
- Contribute to operational excellence initiatives, such as improvement projects, to enhance regulatory efficiency and effectiveness.
Main Contacts:
- Internal: All functions within Sobi, with a focus on Commercial, Pharmacovigilance & Patient Safety, Supply Chain, Quality, Manufacturing & Supply, Clinical Development, Global Medical & Scientific Affairs, Project & Portfolio Management, Management Teams, Governance Teams, and affiliates.
- External: Regulatory authorities, CROs, consultants, and partners.
