Regulatory Planning & Publishing Specialist

About the role

The Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety submissions to assist in planning, execution, and management of activities that deliver high‑quality and timely regulatory submissions. The incumbent may also support internal or external process improvement initiatives to increase the efficiency and effectiveness of RPP processes and deliverables.

Key responsibilities

• Participate in planning forum meetings with the submission planning team, assisting with submission activities and identifying, assessing, and communicating risks or issues that could affect successful completion.
• Identify business process improvement opportunities, update documentation, and develop training to prevent quality deviations or non‑compliance events.
• Liaise with all areas of the RPP organization to ensure timely and quality submissions as required by the business.
• Create and maintain submission plans in the planning tool, ensuring correct components and timelines are captured.

Required profile

• Bachelor’s degree plus at least 2 years of relevant experience.
• Minimum 2 years of experience in healthcare/consumer‑care industry, project management, regulatory affairs, or pharmacovigilance/risk management.
• Strong English communication skills, both verbal and written, in a cross‑functional, matrix environment.
• Ability to understand tactical details while keeping the overall “big picture” view of projects and strategies.
• Self‑starter with strong analytical, problem‑solving, and innovation capabilities; able to perform in a fast‑paced team.
• Highly organized with keen attention to detail and demonstrated leadership and ownership of deliverables.

Required skills

• Microsoft Word
• Advanced Excel (MS Office)
• Electronic Common Technical Document (eCTD)