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Responsibilities:

• Plan and execute CTA submission and amendments in ex-US countries for an oncology asset in pivotal clinical development.
• Provide oversight to global regulatory activities ?that are performed by Clinical Research Organizations (CROs) and regulatory vendors.
• Provide regulatory input and guidance to clinical study teams to expedite the submissions of regulatory documents and ensure regulatory compliance of study activities.
• Coordinate with the relevant team members to address any queries received from Health Authorities pertinent to CTA.
• Keep on top of study status and regulatory submission activities for assigned studies; identify regulatory risks and propose mitigations effectively, and communicate risks, impact, and mitigations to regulatory management working closely with the Regulatory Program Lead.
• Manage and keep track of timelines for ex-US regulatory submissions related to commitment and responses to Health Authorities.
• Provide support to senior Regulatory Affairs staff and management as needed.

Requirements:

• B.S and/or M.S. in Life Sciences and 3+ years of relevant experience in Regulatory Affairs, and oncology development experience is preferred.
• Solid knowledge and experience in interpretation of regulations, guidelines and precedents innovative drug development in the US and Europe.
• Capable and experienced in leading and managing IND or CTA submissions.
• Problem-solving mindset, detailed oriented, sense of urgency and collaborative.
• Excellent written and verbal communication skills.