Spain Pharmaceutical Affairs Specialist - Iberia

Santen Inc; Madrid; Presencial; EUR 45.000 - 60.000; Jornada completa

Descripción de la vacante

A global life sciences company is seeking a Pharmaceutical Affairs Specialist in Spain. The successful candidate will ensure regulatory compliance, support market access initiatives, and maintain relationships across Spain and Portugal. Candidates should have at least 3 years of experience in Regulatory Affairs, fluency in Spanish and English, and a degree in Life Sciences. This role offers a chance to work in a diverse team and contribute to important health initiatives.

Formación

• Minimum 3 years of Regulatory Affairs experience in multinational pharma.
• Knowledge of GxP, medical device regulations, and EU/national frameworks.
• Experience in SOP creation and document management.

Responsabilidades

• Develop product registration plans and communicate with management.
• Prepare and submit Marketing Authorization Applications to local authorities.
• Manage safety-related and regulatory data documentation.

Conocimientos

Regulatory Affairs

Quality Assurance

Pharmacovigilance

Fluent in Spanish

Fluent in English

Organizational skills

Cross-functional collaboration

Educación

University degree in Life Sciences

Master’s in Regulatory Science

Descripción del empleo

Spain) Pharmaceutical Affairs Specialist - Iberia

Full-time

Company Description

Santen is a specialized life sciences company with over 130 years of heritage, focused exclusively on ophthalmology. As a Japan-originated, global company present in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues worldwide.

Job Description

We are seeking a Pharma Affairs Specialist to join our team in Spain. This role offers a unique opportunity to work across Regulatory Affairs, Quality, Pharmacovigilance, and Public Affairs. You will ensure regulatory compliance, support market access initiatives, and maintain relationships with health authorities and internal stakeholders across Spain and Portugal.

Responsibilities

1. Assist in developing product registration plans, strategies, and communicate with management.
2. Prepare and submit Marketing Authorization Applications to local authorities and maintain post-market regulatory dossiers.
3. Manage safety-related and regulatory data documentation according to policies and regulations.
4. Ensure compliance with SOPs, report deviations, and support CAPAs.
5. Conduct pharmacovigilance activities, support audits, and liaise with local departments on safety matters.
6. Support audits of partners and vendors, and perform due diligence activities.
7. Develop local procedures for regulatory compliance and evaluate process improvements.
8. Identify procedural gaps, implement solutions, and support training activities.
9. Maintain regulatory licenses, act as a point of contact for Farmaindustria & Fenin Codes of Practice.
10. Coordinate QA activities, support drug shortage management, and ensure quality system compliance.
11. Serve as local QP and Technical Director for Medical Devices.
12. Ensure awareness of regulatory obligations across the supply chain.
13. Support Public Affairs activities and stakeholder engagement.
14. Monitor inventory levels, manage stock risks, and coordinate with supply chain teams.
15. Travel up to 10% for audits and stakeholder engagement.

Qualifications

• University degree in Life Sciences; Master’s in Regulatory Science or related field is a plus.
• Minimum 3 years of Regulatory Affairs experience in multinational pharma, preferably with Spain and Portugal responsibilities.
• Experience in QA, PV, and Compliance functions.
• Knowledge of GxP, medical device regulations, and EU/national frameworks.
• Experience in SOP creation and document management.
• Familiarity with industry codes and practices (EFPIA, Farmaindustria).
• Fluent in Spanish and English; Portuguese is a plus.
• Strong organizational, communication, and cross-functional collaboration skills.
• Solution-oriented, proactive, adaptable, and resilient.

Additional Information

Join Santen to grow your career and contribute to our vision outlined in Santen 2030, aiming to address social and economic needs of visually impaired individuals. We promote diversity, inclusivity, and flexible working arrangements. We are an Equal Opportunity Employer. If accommodations are needed during recruitment, please inform us.

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