Regulatory Affairs Specialist
hace 4 semanas
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Direct message the job poster from Solutia
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 (annual ODDs, IB, IND submissions, etc.
)Coordination and update of regulatory documents such as SmPC, PIL, mock-ups, RMP, etc.Coordination and review of module 1 regulatory documentsRegulatory Intelligence: regulatory updates for EMA and FDARegulatory internal support in the MAA and FDA filing: dossier elaboration, support in module 1 and regulatory administrative activities, review of eCTD sequencing.Documentation management and tracking for internal archive and audits/inspections.Requirements: University degree in health sciences, a biological science, chemistry or related fieldAccumulated experience of minimum 3-5 years in Regulatory Affairs positionsGood written and verbal communication skills in EnglishDemonstrated direct interaction with regulatory authoritiesDemonstrated coordination of regulatory process.Knowledge of relevant regulatory processes in Europe, desirable in in other territories i.e.
Middle East, US, Asia.Ability to manage multiple tasks/projects/priorities and complex issuesIndependently manages complex technical documents and proceduresExcellent teamwork abilitiesDemonstrated contribution to European submissions (Centralised, Decentralised or Mutual Recognition Procedures) and approvals in EU.Coordination and contribution to life-cycle maintenance activities (product information and variations)Seniority levelSeniority levelAssociateEmployment typeEmployment typeFull-timeJob functionJob functionScienceIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Solutia by 2x
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