Scientific Affairs Specialist

Descripción del empleo

About Nordic Pharma is a mid-size privately-owned international pharmaceutical company which focuses on the development and commercialization of niche hospital and orphan products to address unmet medical needs. Nordic Pharma’s expertise relies on the development and sales of its own products, but also on partner products acquired at various stages of development. Today, Nordic Pharma has a range of highly specialized proprietary and in-licensed products in the following therapeutic areas: Rheumatology, Women’s Health, Ophthalmology, Pediatrics and Critical Care. Nordic Pharma’s values of Commitment, Ambition, Respect, Reliability, Integrity and Agility describe our culture and standards and guide us in our way of working.

Job title: Scientific Affairs Specialist

Location: Madrid, Spain

We are seeking a Scientific Affairs Specialist to join our team in Madrid.

The Scientific & QA Specialist supports Quality Assurance, Regulatory Affairs, Pharmacovigilance and Medical Affairs activities within Nordic Pharma Spain. This role ensures compliance with local and applicable regulations, internal standards, and ethical guidelines. This position contributes to product quality, regulatory maintenance, continuous monitoring of safety, and the scientific/medical oversight required to support healthcare professionals, internal teams, and product lifecycle management.

• This is an exciting opportunity for a motivated and detail-oriented life sciences professional who is eager to develop within Scientific Affairs and contribute to a fast-paced environment.
• The role is ideal for a candidate with 2–3 years of experience in Quality Assurance, Regulatory Affairs, Pharmacovigilance, or Medical Affairs within the pharmaceutical industry.
• The successful candidate will bring knowledge of GxP regulations, regulatory frameworks (EMA, FDA, ICH, WHO), and pharmacovigilance legislation, along with experience in scientific or medical review, regulatory submissions, or quality documentation.
• Strong communication skills in both English and Spanish (written and spoken) are essential.
• The position requires strong scientific and analytical thinking, high attention to detail, a strong compliance mindset, and the ability to interpret complex regulatory and scientific information in a clear and structured manner.

Quality Assurance

• Support the implementation and maintenance of the local Quality Management System (QMS) in alignment with GxP requirements, ISO standards, and company SOPs.
• Manage Product Quality Complaints (PQCs), deviations, CAPAs, change controls, investigations, and risk assessments at affiliate level.
• Support local product recall activities in coordination with Corporate QA.
• Participate in local audits, supplier audits, and health authority inspections.
• Support qualification and validation activities for local customers, suppliers, distributors, and service providers.
• Review, maintain, and update local quality documentation (SOPs, records, reports).
• Contribute to local quality and compliance training activities.

Regulatory Affairs

• Oversight Regulatory Affairs activities for Global Pharmaceutical Products, including submissions, renewals, variations, notifications, and maintenance of product registrations.
• Manage RA submissions for Local Pharmaceutical products, Medical Devices and Food Supplements.
• Ensure regulatory compliance of local labelling, artwork, product information, and promotional materials.
• Maintain local regulatory documentation and databases, ensuring audit readiness.
• Monitor regulatory updates and assess impact on products and internal stakeholders.
• Coordinate responses to local health authority requests and coordinate regulatory actions with cross‑functional teams.

Pharmacovigilance

• Assist Global Pharmacovigilance in preparing safety documentation, when required.
• Perform reconciliation of Product Quality Complaints with safety-related cases.
• Maintain local PV system documentation and support audits and inspections.
• Act as back-up to the Local Safety Officer (LSO), where applicable.
• Promote PV awareness and reporting obligations within the affiliate.

Medical Affairs

• Support local medical projects and activities.
• Respond to medical information requests from healthcare professionals and patients in a compliant and timely manner.
• Support literature reviews, scientific content development, and product knowledge dissemination.
• Contribute to training of local commercial and cross-functional teams on product, therapeutic area, and compliance topics.
• Assist in managing relationships with key opinion leaders (KOLs) when required, ensuring interactions follow compliance rules.

If you are interested in this exciting challenge, we look forward to receiving your application.

We are an equal opportunity employer committed to build a working culture that embraces diversity and inclusion.

All qualified applicants will be considered.

Información extra

Status

Activa

Estudios requeridos

E.S.O

Localización

Madrid

Tipo de contrato

Trabajo estudiantes

Publicado el

21-02-2026

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Español