Iberia Regulatory Affairs Lead – Strategy & Lifecycle

Bayer CropScience Limited; Carnaxide; Presencial; EUR 65 000 - 110 000; Tempo integral

Resumo da oferta

Bayer CropScience Limited seeks a Regulatory Affairs Manager for Iberia to own regulatory strategy, lifecycle plans, and submissions for assigned categories across Spain and Portugal. You will provide regulatory guidance to local stakeholders and coordinate with regional and global colleagues to ensure compliant market access.

The role covers medicines, herbal products, cosmetics, medical devices and food supplements, requiring strong regulatory knowledge and cross-functional collaboration

Qualificações

• Education: scientific degree at least in a relevant field.
• Experience: typically 3–5 years in Consumer Health Regulatory or related Regulatory Affairs roles.
• Knowledge: regulatory requirements for medicinal products in Iberia; cross‑functional collaboration.

Responsabilidades

• Develop, own and implement regulatory strategy and lifecycle plans for Iberia.
• Prepare, coordinate and support submissions, variations, renewals, PSURs and labelling activities.
• Maintain dossiers for medicines, devices and cosmetics per statutory requirements.
• Provide regulatory advice to Spain and Portugal stakeholders on launches and changes.
• Identify regulatory risks and escalate to Iberia RA leadership as appropriate.
• Collaborate with local, regional and global teams to resolve issues and support risk management.
• Liaise with health authorities in Spain and Portugal and with trade associations as needed.
• Monitor regulatory developments impacting the assigned portfolio and ensure implementation.

Conhecimentos

Regulatory affairs

Cross-functional collaboration

Regulatory submissions

Lifecycle management

Portuguese language

English language

Formação académica

Scientific degree (PhD/PharmD or equivalent)

Descrição da oferta de emprego

Bayer CropScience Limited seeks a Regulatory Affairs Manager for Iberia to own regulatory strategy, lifecycle plans, and submissions for assigned categories across Spain and Portugal. You will provide regulatory guidance to local stakeholders and coordinate with regional and global colleagues to ensure compliant market access.

The role covers medicines, herbal products, cosmetics, medical devices and food supplements, requiring strong regulatory knowledge and cross-functional collaboration