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 requiredtimeframes.
The Sr SpecialistRegulatory Publishing,provides technicalexpertiseto cross-functional submission project teams, to promote and bring excellence in planning,preparationand 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 isrequired.
The Sr SpecialistRegulatory 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 willassistin other activities as needed. It is expected that Sr SpecialistRegulatoryPublishing,will 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), compilation,Validationand 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,validationandtimelysubmission 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 technologies,toolsandindustry 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 (eCTD,NeeS, etc.) and lifecycle management concepts and communicates regional differences asappropriate withinthe context of global submission preparation.
Essential Skills/Experience:
A minimum of aBachelor’sdegree in a scientific or technical discipline isrequired; 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 isrequiredand 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 medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca's Alexion division, you'll 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, you'll thrive in a culture that values connection and exploration. Supported by exceptional leaders and peers, you'll 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-2025Closing Date
18-ene-2026Alexion 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 lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (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 an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
Gå med i vår talanggrupp
