Sr. Specialist, Regulatory Publishing

Barcelona - Spain

Monthly Salary: Not Disclosed

Posted on: 10 hours ago

Vacancies: 1 Vacancy

Job Summary

Location: Barcelona Spain (Hybrid Model)

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

The Sr SpecialistRegulatory Publishing is accountable for managing the routine and non-routine submission activity for Alexions portfolio. The Sr SpecialistRegulatory 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 requiredtimeframes.

The Sr SpecialistRegulatory Publishingprovides technicalexpertiseto cross-functional submission project teams to promote and bring excellence in planningpreparationand 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.

The Sr SpecialistRegulatory Publishingwill 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 willassistin other activities as needed. It is expected that Sr SpecialistRegulatoryPublishingwill be significantly involved in publishing activities and will also contribute to archiving activities.

Accountabilities/Duties:

Responsible for the preparation of documents for publishing(both internal and outsourced to publishing vendor) compilationValidationand QC of regulatory submissions to Regulatory Health Authorities (e.g. FDA and EMA) including but not limited to IND BLA/NDA/MAA INDprotocol amendments investigator updates CMC/clinical amendmentsmeeting requests and briefing books

Provides operational oversight for the planning preparation publishingvalidationandtimelysubmission of assigned applications (IND BLA MAA etc.) updates amendments and variations to global regulatory agencies

ManagesRegulatory 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 ofRIM (Regulatory Information Management) systems

Participates in compliant andtimelyarchiving of regulatory submissions and correspondencesin RIM system

Involved in regulatory submission process improvements activities andestablishingrepeatable processesutilizingkey technologiestoolsandindustry best practices

Participatesin 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 globalsubmissionsexpert ensures the project team has sufficient awareness and knowledge of e-submissions (eCTDNeeS etc.) and lifecycle management concepts and communicates regional differences asappropriate withinthe context of global submission preparation.

Essential Skills/Experience:

A minimum of aBachelorsdegree in a scientific or technical discipline is; 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 isand 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 and build relationships with cross-functional teams.

Bachellosdegree.
2ñaosdeexpiernicaen la industria

Self-motivated and results-oriented with high energy drive

Knowledgeable of eCTD templates and structure of Modules (1-5)

Strong knowledge of Microsoft Office suite Adobe Acrobat Adobe Plug-Ins (e.g.ISIToolbox) electronic document management systems eCTD publishing tools eCTD validation and viewing tools.

Solid experience and knowledge of SharePoint technologyand RIM systems(Preferably VeevaVault)isdesired.

In-depth knowledge ofStartingPointtemplates.

Demonstrated project management organizational and planning skills.

Ability to multi-task pay close attention to detail and follow projects through to completion to meet deadlines.

Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities.

Must be able to adhere to strict project timelines and toadviseteams and management of impacts and changes in project timelines.

Good understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met ona timelymanner and to the highest quality.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZenecas Alexion division youll find a place where innovation meets purpose. Our commitment to rare diseases means your work directly impacts lives. With a rapidly expanding portfolio and an entrepreneurial spirit akin to a leading biotech youll thrive in a culture that values connection and exploration. Supported by exceptional leaders and peers youll be empowered to grow your career while making a difference where it truly counts.

Ready to make an impact Apply now to join our team!

Date Posted

22-dic-2025

Closing Date

18-ene-2026

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.

Required Experience:

Senior IC

Location: Barcelona Spain (Hybrid Model)This role requires working from the office 03 days per week. The Sr SpecialistRegulatory Publishing is accountable for managing the routine and non-routine submission activity for Alexions portfolio. The Sr SpecialistRegulatory Publishing in collaboration with...