Quality Assurance & Regulatory Affairs Specialist - Temporary position
On-site · Madrid, Madrid, Spain
Job Summary
Quality Assurance & Regulatory Affairs Specialist to support GDP-compliant QA/QC activities and regulatory affairs in the Iberia region (Spain), with a temporary assignment based in Madrid. Responsibilities include ensuring products are managed, released, stored, and distributed per regulatory requirements; maintaining robust Quality Systems; managing deviations, complaints, and investigations; coordinating significant investigations including fact findings; supporting audits and regulatory agencies; handling regulatory submissions (labelling, SPC updates, deficiency letters, renewals and variations); preparing and reviewing SOPs for regulatory and quality assurance procedures; maintaining regulatory databases; ensuring initial and continuous GDP training; and liaising with health authorities to support product launches. Requirements include a Health Sciences degree and a Master’s in Quality and Regulatory Affairs, 2-3 years in pharma QA/regulatory, SAP knowledge, eCTD/module 1 familiarity, English proficiency, and strong teamwork and organizational skills. Location: Madrid, Spain.
Required Qualifications
- Health Sciences Degree in Pharmacy, Biology, Chemistry
- Postgraduate Degree or Masters in Quality and Regulatory Affairs in the pharmaceutical industry
- 2-3 years of experience in the quality department in the pharmaceutical industry
- Knowledge and management of SAP
- Knowledge of eCTD structure for preparation of module 1
- Awareness of regulatory affairs environment, EU-wide legal framework, and European authorities’ websites
- Proficient knowledge of the English language
- Quality orientation and attention to detail
- Ability to establish relationship with other departments, work in a team and adaptability skills
- Self starter mind-set and proactivity
- Based in Madrid
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