Publishing Manager, Global Regulatory Operations

Are you ready to make a significant impact in the world of regulatory operations? As a Publishing Manager, you will be the primary point of contact for project and submission teams, including Regulatory Submission Project Management, for major projects that require substantial planning and oversight. You will provide technical expertise to cross-functional submission project teams, driving excellence in the planning, preparation, and delivery of regulatory submissions. Your guidance on both electronic and paper submission requirements will be crucial in ensuring compliance and quality.

Accountabilities

1. Managing and coordinating both routine and non-routine submission tasks across Alexion’s portfolio, such as publishing, scheduling, submission compilation, quality control (QC), validation, dispatch, and archiving of electronic and paper submissions as necessary.
2. Overseeing the publishing and preparation of high-quality global submission dossiers, ensuring timely and compliant submissions to global health authorities.
3. Supporting the Associate Director, Regulatory Publishing, in activities related to setting standards, best practices, collecting KPIs, developing new procedures, creating work instructions, and disseminating lessons learned, while assisting in other activities as needed.
4. Assisting with dossier management and archiving and mentoring junior publishers and other team members involved in publishing tasks.
5. Collaborating with the Regulatory Business System Support Lead and other stakeholders, including IT, to plan and implement upgrades for publishing and validation systems at Alexion.
6. Contributing to the evaluation, development, and implementation of systems and processes to support regulatory activities, such as planning, tracking, document management, publishing, and archiving (e.g., Regulatory Information Management).

Qualifications

1. Bachelor’s degree in a scientific or technical discipline with at least 10 years relevant experience.
2. An understanding of regulatory processes and regulations, across all stages of drug development (preapproval, authorization and post marketing).
3. Ability to manage multiple stakeholders and build team relationships to collaborate in a global team environment at all levels of the organization.
4. Experience authoring standards documents (Standard Operating procedures) or process maps.
5. Experience with the development, implementation, maintenance, and ongoing customer support for regulatory processes.
6. Ability to manage complex issues and demonstrated ability to influence effectively and implement change in complex matrix organizations.
7. Experience with Veeva Vault preferred.
8. Detail oriented.
9. Excellent written and verbal communication skills.

Ready to join our team? Apply now!