Hybrid [Spain] Pharmaceutical Affairs Specialist - Iberia bei Santen

Santen is a specialized life sciences company with a proud over 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with a footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 

We are looking for a Pharma Affairs Specialist to join our team in Spain. This role offers a unique opportunity to work at the intersection of Regulatory Affairs, Quality, Pharmacovigilance, and Public Affairs. You will play a key role in ensuring regulatory compliance, supporting market access initiatives, and maintaining strong relationships with health authorities and internal stakeholders across Spain and Portugal.
 

What you will do
    •    Assist in the development of product registration plans and strategies, working cross-functionally to review and communicate the registration strategy with management oversight; assist in the timely preparation and submission of new Marketing Authorization Applications to local Health Authorities, as well as the maintenance of authorized products through post-market regulatory dossiers (variations, renewals, supplemental marketing authorizations) in accordance with local regulations and global standards.

    •    File, store, and archive safety-related and regulatory data and documentation under department and company policies and local requirements; act in full compliance with global and local SOPs, report any deviations or compliance concerns immediately, and assist in preparing necessary corrective and preventive actions (CAPAs) locally for non-compliance issues.

    •    Conduct local Pharmacovigilance activities in alignment with the EMEA PV department and support local PV audits and inspections, including readiness activities and response to findings; liaise with the local department to keep them apprised of safety activities and provide strategic decisions (e.g., product launches) with management oversight.

    •    Participate in and support audits of contractual partners/vendors as necessary; may be trained and assigned responsibility to conduct qualification and ongoing audits of vendors, and to perform due diligence activities for local country licensing agreements.

    •    Assist in developing local procedures (in compliance with regional and global standards) for the department to ensure quality RA data, and evaluate processes for potential improvement in efficiency and effectiveness; proactively identify procedural gaps and challenges and implement solutions in collaboration with all affected stakeholders.

    •    Support training of local company staff, distributors, vendors, and business partners, including training documentation; contribute to the maintenance of regulatory licenses, including but not limited to product licenses, import and distribution of pharmaceuticals and medical devices.

    •    Act as Farmaindustria & Fenin Code of Practice warrant and point of contact within Santen Pharmaceutical Spain S.L.; act as QA link and coordinate QA-related activities between local (Spanish and Portuguese) health authorities and the Santen EMEA QA department, and coordinate local external partners as needed.

    •    May be assigned to support drug shortage management and regulatory reporting requirements, including collaboration with the Head Quality Assurance’s EMEA Team to avoid supply constraints and ensure constant audit-readiness; implement and guarantee the Quality System, develop corporate procedures, manage the Compliance Veeva system in the affiliate, and support SOP development and updates.

    •    Act as local QP and local Technical Director for Medical Devices; as delegated, ensure awareness of obligations to comply with regulatory and statutory requirements and top management decisions across the establishment and supply chain; execute Public Affairs activities supporting Government Affairs strategies; manage and strengthen relationships with regulators, policymakers, and stakeholders at local, national, and international levels if required; support compliance activity across departments and the development of communication materials to assess the impact of regulatory changes in collaboration with Market Access, Compliance, and local teams.

    •    Regularly monitor product inventory levels, identify potential stock-out risks and anticipate future needs; collaborate closely with the Supply Chain and Logistics teams to manage stock levels, coordinate actions in case of backorders, and track pending deliveries and estimated restock dates to ensure product availability.

•    Travel occasionally (up to 10%) to support local and regional activities, audits, or external stakeholder engagement.

What you will bring to the role

    •    University degree in Life Sciences; Master’s in Regulatory Science or related specialization is a plus.
    •    Minimum 3 years of experience in Regulatory Affairs in multinational pharmaceutical companies, ideally with responsibilities across Spain and Portugal.
    •    Demonstrated experience in local QA, PV, and Compliance functions; knowledge of GxP (especially GMP/GDP) and medical device regulations.
    •    Strong understanding of EU and national regulatory frameworks and procedures; familiarity with SOP creation and document management practices.
    •    Deep knowledge of EFPIA, Farmaindustria, and relevant Spanish and Portuguese codes and industry practices.
    •    Excellent interpersonal and communication skills, both written and spoken, in Spanish and English (Portuguese is a plus).
    •    Strong organizational influence, ability to work cross-functionally in dynamic, multicultural environments.
    •    Solution-oriented mindset, proactive in identifying gaps and driving improvements.
    •    Entrepreneurial approach with a passion for learning, adaptability, and resilience under changing conditions.

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.