Sr. Specialist, Regulatory Publishing

Location: Barcelona, Spain (Hybrid Model)

This role requires working from the office 03 days per week.

The Sr Specialist, Regulatory Publishing, is accountable for managing the routine and non‑routine submission activity for Alexion’s portfolio. The Sr Specialist, Regulatory Publishing, in collaboration with the Regulatory Lead, designs and executes high quality global submission plans, ensuring Alexion delivers compliant submissions to global health authorities within required time frames.

The Sr Specialist, Regulatory Publishing, provides technical expertise to cross‑functional submission project teams, to promote and bring excellence in planning, preparation and delivery of regulatory submissions, and will act as the primary point of contact for project and/or submission teams when significant planning effort and oversight is required.

The Sr Specialist, Regulatory Publishing, will also support the Submission Operations Lead and/or Submission Manager, in activities related to setting standards, best practices, KPI collection, developing new procedures and work instructions, lessons learned dissemination and will assist in other activities as needed. It is expected that Sr Specialist Regulatory Publishing, will be significantly involved in publishing activities and will also contribute to archiving activities.

• Responsible for the preparation of documents for publishing (both internal and outsourced to publishing vendor), compilation, Validation and QC of regulatory submissions to Regulatory Health Authorities (e.g., FDA and EMA), including but not limited to IND, BLA/NDA/MAA, IND, protocol amendments, investigator updates, CMC/clinical amendments, meeting requests and briefing books.
• Provides operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (IND, BLA, MAA, etc.), updates, amendments, and variations to global regulatory agencies.
• Manages Regulatory document submission readiness activities.
• Involved in development and implementation of standards for dossier management, publishing, archiving and submission process for global regulatory authorities.
• Participates in validation activities for the implementation of RIM (Regulatory Information Management) systems.
• Participates in compliant and timely archiving of regulatory submissions and correspondences in RIM system.
• Involved in regulatory submission process improvements activities and establishing repeatable processes utilizing key technologies, tools and industry best practices.
• Participates in cross‑functional project teams to provide publishing strategies and timelines.
• Participates and shares lessons learnt sessions to encourage process improvement and efficiencies within and across submission project teams.
• Negotiates and agrees on realistic dates for document handoffs in collaboration with the authors and publishers.
• Performs publishing and dossier compilation of routine and non‑routine eCTD and other submissions, as needed (and as assigned).
• In collaboration with the regulatory lead, manages the development and maintenance of a global submission content map, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval and publishing.
• As a global submissions expert, ensures the project team has sufficient awareness and knowledge of e‑submissions (eCTD, NeeS, etc.) and lifecycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.

• A minimum of a Bachelor’s degree in a scientific or technical discipline is required; equivalent experience may be accepted.
• A minimum of 4 years pharmaceutical or other related industry experience with 1-3 years of regulatory submission management experience.
• Solid experience in publishing and compilation of eCTD submissions for US and EU filings is required and experience publishing electronic submissions in other regions is desirable.
• Strong verbal and written communication and presentation skills.
• Strong interpersonal skills and ability to work effectively…