Regulatory Affairs Manager - Iberia

Bayer AG; Carnaxide; Presencial; EUR 85 000 - 115 000; Tempo integral

Resumo da oferta

Bayer is seeking a Regulatory Affairs Manager – Iberia to own regulatory strategy and lifecycle plans for assigned categories across Spain and Portugal, including medicines, cosmetics and medical devices. You will coordinate submissions, update dossier content, and liaise with local authorities and cross-functional teams to ensure compliant market access.

The role requires 3–5 years in regulatory affairs, strong knowledge of Portuguese and European requirements, and excellent communication to

Qualificações

• Education: scientific degree such as PhD, PharmD or equivalent.
• Typically 3–5 years in Consumer Health Regulatory Affairs or related roles.
• Experience with regulatory submissions and lifecycle management.
• Knowledge of Portuguese national and European medicinal product requirements mandatory.
• Cross-functional collaboration across countries and functions.

Responsabilidades

• Develop, own and implement regulatory strategy and lifecycle plans for assigned categories and brands within Iberia, in line with local, cluster and regional priorities.
• Prepare, coordinate and support submissions, variations, renewals, PSURs, authority responses, labeling updates and local text changes.
• Maintain dossiers and documentation for medicines, devices, foods and cosmetics per statutory requirements.
• Provide regulatory advice to Spain and Portugal stakeholders on launches and changes.
• Identify regulatory risks and escalate recommendations to Iberia RA leadership as appropriate.
• Collaborate within country, cluster, regional and global teams to resolve product issues and support risk management.
• Liaise with health authorities in Spain, Portugal and PALOP; participate in trade association activities as appropriate.
• Monitor regulatory developments affecting the assigned portfolio and ensure implementation follow-up.
• Maintain regulatory information, tracking, reporting and databases to ensure compliance.

Conhecimentos

Execution Excellence

Consumer Focus

Business Acumen

Team Player

Problem Solving

Attention to Detail

Commercial Awareness

Adaptability

Communication Skills

Portuguese

English

Spanish

Formação académica

Scientific degree (PhD/PharmD or equivalent)

Descrição da oferta de emprego

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Regulatory Affairs Manager - Iberia

CH Regulatory Affairs Iberia – Regulatory Affairs Manager

Position

Regulatory Affairs Manager – Iberia

Main purpose

Responsible for regulatory management, strategic ownership and lifecycle execution for an assigned portfolio within Iberia, covering medicinal products, herbal medicinal products and other relevant product categories including cosmetics, medical devices and food supplements.

As a member of the Iberia Regulatory Affairs team, provides regulatory guidance to local business stakeholders and regional/global functions across Spain and Portugal on regulatory strategy, processes, risks, market-specific requirements, authority expectations and local implementation needs.

Serves as an RA contact and regulatory subject matter expert for the assigned portfolio across Iberia, escalating material risks, issues and recommendations to Iberia RA leadership as appropriate.

Scope

Iberia: ES, PT and PALOP markets as applicable

Key figures

• Direct reports: 0
• Managed positions: 0
• Financial figure: to be confirmed; assigned portfolio sales to be aligned with relevant Iberia category/sub-portfolio planning assumptions.

Key tasks & responsibilities

• Develop, own and implement regulatory strategy and lifecycle plans for assigned categories and brands within Iberia, in line with agreed local, cluster and regional priorities.
• Prepare, coordinate and support submissions, variations, renewals, PSURs, authority responses, labelling, artwork, local text updates, CMC updates and implementation activities for the assigned portfolio.
• Maintain medicine dossiers, medical device technical files, food supplement and cosmetic documentation for the assigned portfolio according to applicable statutory requirements.
• Provide regulatory advice to Spain and Portugal business stakeholders on launches, claims, product changes, artworks, portfolio activities and local implementation topics.
• Identify regulatory risks, issues and options for the assigned portfolio, escalating material recommendations to Iberia RA leadership as appropriate.
• Collaborate within the country, cluster, regional and global organization to resolve product-related issues and support risk management activities for assigned categories and brands.
• Liaise with Spanish and Portuguese health authorities and other competent bodies for assigned topics, in coordination with relevant Iberia, regional or global colleagues.
• Act as the local Regulatory Affairs representative for Portugal at relevant Portuguese trade association regulatory committees, and represent Bayer in Spanish or wider Iberian trade association activities where appropriate, ensuring alignment with Iberia RA strategy and agreed business priorities.
• Monitor Spanish, Portuguese, Iberian and relevant European regulatory developments impacting the assigned portfolio and ensure appropriate communication, mitigation and implementation follow-up.
• Maintain accurate regulatory information, tracking tools, reporting and databases for the assigned portfolio, ensuring compliance obligations are met.
• Prepare, review, maintain and archive regulatory documentation and correspondence to a high-quality, right-first-time standard.
• Provide RA input to inspections, quality investigations, complaints, recalls, shortage notifications and CAPA activities as required.

Key working relations

Internal

• Country, Cluster, Regional and Global Regulatory Affairs teams.
• Iberia Regulatory Affairs leadership and category stakeholders.
• Local BCH departments, including Commercial, Marketing, Medical, Drug Safety, Quality, Supply, CDH and other relevant business functions in Spain and Portugal.

External

• Health Authorities and competent bodies in Spain, Portugal and PALOP markets as applicable.
• Portuguese trade association regulatory committees, where the role acts as local RA representative; Spanish and wider Iberian industry associations and regulatory committees as appropriate.
• External experts, consultants and service providers as appropriate for assigned activities.

Qualifications & competencies

• Education: scientific degree, such as PhD, PharmD or equivalent qualification.
• Experience: typically 3–5 years of experience in Consumer Health Regulatory Affairs or related Regulatory Affairs roles, preferably within the pharmaceutical industry.
• Hands-on experience with regulatory submissions, lifecycle management, labelling/artwork activities and operational regulatory delivery.
• Knowledge of Portuguese national and European regulatory requirements for medicinal products is mandatory; knowledge of Portuguese requirements for medical devices, food supplements and/or cosmetics and Spanish regulatory requirements is desirable.
• Experience working cross-functionally with teams across countries and functions, including local business stakeholders and regional or global regulatory colleagues.
• Demonstrated ability to develop and execute regulatory activities for an assigned portfolio, supporting business objectives while ensuring appropriate governance, compliance and escalation of risks.
• Competencies: Execution Excellence, Consumer & Customer Focus, Business Acumen, Team Player, Problem Solving, Attention to Detail, Commercial Awareness and Adaptability.
• Communication Skills: ability to explain complex scientific and regulatory topics in an understandable way and connect them to business impact.
• Language Skills: professional fluency in Portuguese and English; Spanish language capability is desirable for broader Iberia collaboration.