Bolsa de empleo – Candidatos

Puesto: Regulatory Affairs Officer

Lugar: Madrid

Entidad: Consultora de Farmacovigilancia y Asuntos Regulatorios

The Regulatory Affairs Officer will support the execution and coordination of local regulatory activities across Iberia (with primary focus on Spain and support to Portugal as applicable), ensuring compliance with applicable local and European regulatory requirements, internal procedures and global regulatory direction. The role will contribute to the maintenance of the marketed portfolio, product information accuracy, regulatory submissions, launch readiness, early access activities and regulatory intelligence. It requires strong attention to detail, sound regulatory judgement and effective collaboration with local and global stakeholders.

Key Responsibilities:

• Prepare, adapt and manage local regulatory submissions to Health Authorities, including variations, renewals, national phase documentation and lifecycle maintenance activities, assessing the local impact of regulatory changes and ensuring timely follow-up until completion.
• Manage product information activities, including review, update, distribution and implementation of SmPCs, package leaflets, abbreviated SmPCs, local product information documents and other regulatory texts. Ensure alignment with approved information, local requirements, official repositories and, where relevant, Therapeutic Positioning Reports (IPTs).
• Review and approve packaging materials, artworks, mock-ups, demo packs and related local labelling documentation, ensuring consistency with approved product information and compliance with local requirements, including specific local elements such as blue box, Braille and national coding requirements.
• Support early access and compassionate use activities by contributing to local strategy discussions, preparing and adapting required documentation, supporting submissions and interactions with Health Authorities, coordinating with global and local functions, and maintaining adequate follow-up, trackers and records.
• Contribute to product launch and pre-launch activities by preparing local regulatory documentation, supporting national code requests, reviewing relevant assessment or positioning documents, coordinating artwork and labelling readiness, and providing regulatory input to cross-functional launch teams.
• Monitor the evolving regulatory environment at local and European level, including relevant Health Authority updates and scientific committee outputs, assess potential impact for the affiliate and escalate significant changes through the appropriate regulatory intelligence channels.
• Develop, review and maintain local Regulatory Affairs procedures and working instructions, ensuring alignment with global processes and supporting the local implementation of new or updated global requirements.
• Ensure accurate regulatory documentation management, including archiving, traceability and maintenance of records in corporate systems and local repositories such as RIM, Veeva Vault, SharePoint or equivalent platforms.
• Provide regulatory support to cross-functional activities, including technical documentation for tenders, certificates, annual regulatory reports, supply-related communications, local product resources and review of promotional and non-promotional materials.
• Support oversight of external vendors involved in regulatory activities, ensuring appropriate coordination, documentation quality, follow-up of deliverables and escalation of issues where needed.
• Participate in regulatory training and continuous development activities, and contribute to onboarding or training of interns, temporary associates or new team members when required.

Profile and Experience:

• University degree in Pharmacy, Life Sciences or a related scientific discipline. Previous experience in Regulatory Affairs within the pharmaceutical industry is required, preferably in a local affiliate environment. Experience with product information management, lifecycle submissions, artwork review, early access activities or launch support will be considered highly valuable.

Key Skills and Competencies:

• Good understanding of European and local pharmaceutical regulatory requirements, with particular attention to Health Authority expectations and local implementation needs.
• Strong organisational skills and ability to manage multiple priorities, deadlines and stakeholders in parallel.
• High attention to detail, document accuracy and traceability, with a compliance-driven mindset.
• Effective written and verbal communication skills, with ability to work cross-functionally with Medical, Market Access, QA, PV, Commercial and global Regulatory teams.
• Proactive, practical and solution-oriented approach, with capacity to escalate appropriately and support continuous improvement of local processes.
• Fluent Spanish and strong professional English. Portuguese knowledge is desirable but not essential.

Working Scope:

• The role is primarily operational, with exposure to Health Authorities, global teams and external partners. It is designed for a Regulatory Affairs professional able to execute core local RA activities independently while progressively contributing to higher-complexity projects, local oversight and strategic regulatory input for the affiliate.

Fecha límite de admisión de CV: 09/07/2026 (inclusive)

Dirección de envío: en esta misma página, más abajo, encontrará el formulario para poder enviar su CV. 

* Debe indicar en el asunto el código del proceso en el asunto.  🟢 

Puesto: Clinical Trial Assistant

Lugar: Alcobendas, Madrid

Entidad: CRO.

Functions:

• Support team in executing clinical trial start-up activities within timelines.
• Prepare reports, meeting minutes, presentations, and track documents.
• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF).
• Maintain training records and attend required internal/external training.

Qualifications:

• Bachelor’s degree required, preferably in Life Sciences or a related field.
• Clinical Trial Assistant course valuable.
• 5 year experience in clinical research (Sponsor, CRO).
• Experience in TMF: Veeva, IQVIA Wingspan, etc is valuable.
• Proficient in Microsoft Teams, Word, Excel, PowerPoint, Outlook, and SharePoint.
• Self-motivated with strong time management and ability to meet deadlines.
• Excellent communication & collaboration skills in a fast-paced environment, must be fluent in English and Spanish.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.

We offer:

• Positive and collaborative work environment.
• Flexible working hours to support work-life balance.
• Stable and long-term employment opportunity.
• Supportive team and continuous learning environment.
• Competitive salary based on experience and skills.

Fecha límite de admisión de CV: 12/06/2026 (inclusive)

Dirección de envío: en esta misma página, más abajo, encontrará el formulario para poder enviar su CV. 

* Debe indicar en el asunto el código del proceso en el asunto.  🟢

Puesto: CRA/Study Coordinator

Lugar: Las Rozas de Madrid

Entidad: CRO.

Formación requerida:

• Imprescindible haber cursado el máster en Monitorización de Ensayos Clínicos.
• Mínimo 2 años de experiencia en monitorización de ensayos clínicos.
• Nivel C1 de inglés.
• Posibilidad de incorporación inmediata.

Se ofrece:

• Contrato indefinido.
• Seguro médico.
• Las condiciones salariales se hablarán en la entrevista.

Fecha límite de admisión de CV: 10/05/2026 (inclusive)

Dirección de envío: en esta misma página, más abajo, encontrará el formulario para poder enviar su CV. 

* Debe indicar en el asunto el código del proceso en el asunto. 🟢