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Regulatory Affairs Specialist

Regulatory Affairs Specialist

SolutiaghsBarcelona, Cataluña, España
Hace 5 días
Descripción del trabajo

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)

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    Regulatory Specialist • Barcelona, Cataluña, España