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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 documents
* Regulatory Intelligence: regulatory updates for EMA and FDA
* Regulatory 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 field
* Accumulated experience of minimum 3-5 years in Regulatory Affairs positions
* Good written and verbal communication skills in English
* Demonstrated direct interaction with regulatory authorities
* Demonstrated 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 issues
* Independently manages complex technical documents and procedures
* Excellent teamwork abilities
* Demonstrated 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 level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Science
* Industries
Pharmaceutical Manufacturing
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