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Regulatory Affairs Specialist

Eingestellt von Quanta Consultancy Services

Gesuchte Skills: Support, Affiliate

Projektbeschreibung

A major Biotechnology/Pharmaceutical organisation based on the Cambridgeshire/Suffolk border has a fantastic opportunity for a Regulatory Affairs Specialist to join the team. The purpose of the role is to prepare CMC components in support of variations in EU and International markets.

The Role:
.Liaise with External manufacturers and internal Corporate Regulatory functions to ensure CMC data components, variations and dossiers are prepared and delivered according to planned regulatory strategies in both the EU and International markets.
.Work with both internal and external regulatory functions to ensure a coordinated approach to document preparation.
.Review proposed changes and evaluate regulatory impact in EU markets and advise on compliance issues.
.Support new site registrations and renewals in EU and International markets.

Experience
.Degree or equivalent
.Minimum 2-3 years regulatory affairs & compliance experience in EU and International markets.
.Experience of National & MRP procedures.
.Experience with EU National and MRP processes and variations guidance.
.Experience working with external manufacturers and affiliate groups.
.Proven ability of managing regulatory projects in EU and International markets - Essential
.Candidates must have experience in Regulatory Affairs in a production environment - Essential

A fantastic hourly rate is on offer alongside an exceptional opportunity to join a major Biotechnology/pharmaceutical organisation.

Please apply today with covering letter highlighting your key skills and relevant experience aligned to this opportunity.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Quanta Consultancy Services