Regulatory Affairs Leader

Proclinical has partnered with a global pharmaceutical organisation in search for a Regulatory Affairs Project Manager. In this role will be responsible for leading projects throughout the regulatory lifecycle

Job Responsibilities

• Whilst strategic development will be involved, the role requires a more hands on project management focus
• You will be expected to ensure cross-functional teams, partners, stakeholders, etc deliver their part of regulatory projects
• You will focus on global oncology studies throughout the entire regulatory lifecycle
• Review labelling, pack leaflets and summary of product characteristics etc. to ensure compliance with current legislation and registered particulars and act, as agreed with supervisor, to secure regulatory approval where necessary

Skills and Requirements

• Life sciences or chemistry degree with proven relevant experience within regulatory in the pharmaceutical industry (country affiliate role for UK & Ireland
• Prior project focused regulatory experience across various global markets is essential
• Strong communication skills are essential and prior experience managing third-party/ CRO relationships is strongly desirable
• Oncology experience is preferred though not essential

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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