Senior Publisher/Regulatory Operations Specialist

Senior Publisher/Regulatory Operation Specialist - Permanent - Remote

Proclinical is seeking a Senior Publisher/Regulatory Operations Specialist to join our team. In this role, you will be instrumental in shaping regulatory strategies and ensuring seamless submissions within a dynamic environment. You will manage complex documentation workflows, uphold quality standards, and collaborate with cross-functional teams to enhance efficiency. Your expertise in electronic submissions and regulatory requirements will be crucial in overcoming industry challenges and delivering impactful solutions. This position is ideal for someone who is detail-oriented, proactive, and thrives in a collaborative setting.

Skills & Requirements:

• Proficient knowledge of IND/BLA/eCTD and other electronic submission guidelines.
• Background in Chemistry or Life Sciences.
• Experience with DocuBridge software.
• Familiarity with the pharmaceutical industry and regulatory affairs.
• Expertise in MS Office, Adobe Acrobat, and electronic/document/data management systems.

Responsibilities:

• Manage and oversee complex documentation workflows.
• Maintain high-quality standards in all regulatory submissions.
• Collaborate with cross-functional teams to drive operational efficiency.
• Navigate and implement electronic submission processes.
• Ensure compliance with regulatory requirements and guidelines.