Specialist, Regulatory Affairs Operations Publishing

Taiho Oncology is looking for a Specialist, Regulatory Affairs Operations Publishing to join their team. The role will involve conducting and supporting global regulatory affairs dossier publishing activities, including document and submission preparation and review, communicating with RA staff and other subject matter experts, and updating regulatory submission trackers. The position will begin to provide in-house publishing in coordination with the publishing vendor resources. The company values its employees and offers a

Requirements

• Conducts and supports global regulatory affairs dossier publishing activities
• Publishes regulatory affairs dossiers for submission to health authorities
• Contributes to the development and implementation of dossier publishing processes and procedures to improve efficiency and meet health authority standards
• Interacts with regulatory affairs and subject matter experts to ensure every published dossier meets health authority and ICH standards
• Effective communication with regulatory colleagues and subject matter experts

Benefits

• 401(k) eligibility
• Paid time off benefits (vacation, sick time, and parental leave)
• Annual bonus/incentive comp plans
• Potential long term incentive plan
• Discretionary awards