Solutia Life Sciences (recruitment division of Solutia) specializes in technical and middle management profiles in the pharmaceutical, biotech, and medical device sectors.
We are currently seeking a Regulatory Affairs Specialist for a leading pharmaceutical company based in El Maresme, Barcelona.
Responsibilities:
* Coordinating regulatory activities, documents and deadlines with other departments (ODDs, IB, IND submissions)
* Coordination and update of regulatory documents such as SmPC, PIL, mock-ups, RMP
* Coordination and review of Module 1 regulatory documents
* Regulatory intelligence: updates for EMA and FDA
* Internal support in the MAA and FDA filing: dossier elaboration, Module 1, admin tasks, eCTD sequencing review
* Documentation management and tracking for internal archive and audits/inspections
What’s offered:
* Hybrid work model: Only 3 days per week on-site, with flexibility depending on team needs.
* Flexible schedule: Core availability required between 10 a.m. and 4 p.m.—the rest of your day is yours to organize. We just ask for availability during team meetings.
* Annual bonus with realistic and achievable targets.
Requirements:
* University degree in health sciences, biological sciences, chemistry or related field
* 3–5 years of experience in Regulatory Affairs
* Fluent English, both written and spoken
* Experience interacting with regulatory authorities and coordinating regulatory processes
* Knowledge of European regulatory procedures (preferably also Middle East, US, Asia)
* Proven contribution to European submissions (CP, DCP, MRP) and life-cycle management (e.g., variations, product info updates)