Pharmaceutical Affairs Manager
Ascendis Pharma
full-time
Posted on:
Location Type: Hybrid
Location: Madrid • Spain
Visit company websiteExplore more
About the role
- Oversee key regulated activities including distribution, storage, import/export, promotion, medical information, and quality documentation.
- Support preparation and submission of regulatory documents such as variations and notifications.
- Support administrative efforts related to regulatory documentation (e.g., Certificado de Exclusividad).
- Ensure compliance with Spanish and Portuguese pharmaceutical laws and other local and EU regulations (GDP/GMP/GVP).
- Review and approve documentation related to pharmaceutical operations, distribution, and product handling.
- Ensure proper storage and transport conditions to maintain product integrity and patient safety.
- Ensure compliance with safety-feature requirements under the EU Falsified Medicines Directive (FMD)
- Support the implementation and continuous improvement of a fit-for-purpose local Quality Management System.
- Approve and follow up on SOPs, quality procedures, and training documentation.
- Participate in internal and external audits, including preparation and corrective actions.
- Manage deviations, complaints, CAPAs, and quality indicators.
- Contribute to supplier qualification and review of technical and quality agreements.
- Support annual product quality reviews and quality documentation activities.
- Support local pharmacovigilance compliance in collaboration with the global safety team.
- Report and follow up on quality and safety-related concerns as required by legislation.
- Act as the key point of contact for Spanish and Portuguese authorities (e.g., AEMPS, Infarmed).
- Ensure inspection readiness and support regulatory or quality inspections.
- Report quality defects, falsified medicines, and other safety-related issues according to Italy and EU regulations, in collaboration with local vendors.
- Work closely with local (and Global) Medical Affairs, Sales, Legal, Quality, Regulatory Affairs, Supply Chain, Compliance, and Finance.
- Provide guidance and support to internal teams on regulatory, quality, and compliance requirements.
Requirements
- Degree in Pharmacy or equivalent (e.g., Medicinal Chemistry)
- Experience with AEMPS interactions on variety of matters
- Minimum 2 years of experience in Regulatory Affairs, Quality, Pharmacovigilance, and/or Distribution within the pharmaceutical industry.
- Knowledge of Spanish pharmaceutical law, EU GDP/GMP/GVP standards, and quality systems.
- Strong English communication skills.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory documentationquality management systemSOPspharmacovigilanceCAPAsquality indicatorssupplier qualificationannual product quality reviewsquality documentation activitiescompliance with EU regulations
Soft skills
communication skillsguidancesupportcollaborationadministrative skillsproblem-solvingattention to detailaudit participationinspection readinessinterpersonal skills
Certifications
Degree in PharmacyMedicinal Chemistry equivalent