Manager - Publishing

Role Overview: You will be responsible for delivering and driving high-quality submissions by yourself and the team in compliance with technical requirements from regulatory authorities. Your main focus will be on fixing any errors, guiding the team, and troubleshooting submissions to ensure a quality output. Additionally, you will drive a first-time-right approach by educating the team and collaborating with other operations teams and stakeholders to work towards common goals. Key Responsibilities: - Fix errors, guide the team, and troubleshoot submissions to ensure quality output - Educate the team on relevant activities to drive a first-time-right approach - Collaborate with other operations teams and stakeholders to achieve common goals - Identify process improvements and deploy them for efficiency gains - Identify gaps/errors and work with affiliates/regional leads/key stakeholders to offer solutions - Optimize resource management by mapping workloads versus resources - Manage the publishing workflow to deliver timely submissions - Stay updated on changes in regulations across countries and adapt the team accordingly - Test new implementations or upgrades of tools used in the organization - Train the team and end-users on publishing systems - Screen for end-user mistakes before raising tickets to optimize ticket costs - Participate in technical discussions with ArisG for Publishing related queries - Contribute to kick-off meetings of eCTD implementation in new countries Qualifications Required: - Minimum of 8-10 years of experience in Submission publishing and Regulatory Affairs - Deep understanding of processes across Pharma and Vaccines product lines - Expertise in eCTD concepts and troubleshooting - Exposure to markets such as RoW (EM), EU, and US (preferred) - Familiarity with various Publishing tools to identify white space and suggest optimization (Note: No additional details about the company were provided in the job description.),