882468 Interim Regulatory Professional

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Attention! This job posting is 7 days old and might be already filled.
Company Name Not Disclosed
Location Virtual, United Kingdom
Category Regulatory
Job Type Interim
Sector Pharmaceutical
Level Manager
Salary/Rate Day rate opportunity

Description

Our client, a privately-owned speciality pharma and contract manufacturing group, focused on the development and commercialisation of niche high value pharmaceuticals is recruiting for a Regulatory Manager for an initial period of 6 months.
You would become one of the leaders within their hard-working team, managing and overseeing the regulatory duties. Ideal for an experienced Interim Regulatory Manager.

Role Purpose:
• Manage requests for proposals and set out scope of work
• Lifecycle management of small molecule products across the EU
• Current dossier compliance maintenance
• Oversight of labelling maintenance – labelling impact assessments where PV feeds in
• NICE and eCTD (electronic common technical document) composition
• Technical agreements, SOPs
• Help QPPV team members identify escalation and risk factors
• Quality Management Systems
• Out licencing agreements
• Help activity surrounding CMC
• GMP, GDP
• Budget management

Requirements include:
• Good knowledge of CMC and risk factors associated PV
• Good knowledge of labelling obligations
• Experience of the submission process from an electronic point of view
• Experience of working with Manufacturing sites
• Experience of managing virtual teams
• Experience of dealing with Health Authorities and managing complex issues
• Experience of supporting the regulatory aspect of clinical trials
• Range of therapeutic and molecule experience

Keywords:

Interim, Regulatory Manager, Virtual working, Small molecule, CMC, Pharma, GMP, GDP

Location: Virtual with a day a week in Dublin

Duration and days per week: 6-12 months, 3-4 days per week

To register your interest in this opportunity please forward an up-to-date CV to resourcing@pir-resourcing.com or contact PiR on 01480 499580, quoting reference 882468 and advising current availability and anticipated day rate.