Regulatory Publishing Manager

Responsible for defining and upholding company publishing standards and practices to meet agency requirements globally. Required to execute against dossier development build and publishing activities, ensuring that the company delivers on all regulatory submission milestones and maintains compliance with applicable regulatory obligations. Must provide technical expertise to partnering business lines to drive excellence in the design, implementation and delivery of regulatory submissions.

KEY ACCOUNTABILITIES

- Delivering project specific paper and electronic submissions. Including co-ordination and execution of publishing solutions that meet unique requirements of each submission, and management of product delivery to regulatory agencies.
- Maintain a working knowledge of electronic and paper publishing systems and tools and how these are applied
- Definition, investigation and implementation of regional and global process efficiencies for paper and electronic submission publishing, including the evaluation of current processes.
- Lead/participate on global/local teams to complete assignments and tasks within a specific task force/project associated with electronic and paper submissions.
- Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
- Work with the Team Managers to effectively forecast and manage project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.
- Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
- Define and implement standards and regional process efficiencies for submission publishing and project learning sessions to meet these standards.
- Operate as Subject Matter Expert in dossier types and/or processes with responsibility for training and mentoring fellow colleagues. Provide Subject Matter Expertise for technical publishing tools and provide efficiency/enhancement proposals for the publishing tool suites.

SKILLS:

4-7 years experience with Graphics and MS Office are required. Must be fluent with multiple dossier formats and publishing requirements.