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Regulatory Affairs and Quality Manager – EU

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Regulatory Affairs and Quality Manager – EU

We are partnered exclusively with one of longest standing clients of the last 10 years, helping them with a critical hire to oversee all regulatory and quality activities for the EU region. As one the world’s most reputable and established companies in its specialist area, this is a fantastic opportunity to take a hands on role in a senior capacity.

The location of this position is flexible.

Key responsibilities/duties:

Regulatory (75%) – some of the key duties include:

* Manage registrations and licenses.

* Review and approve labelling, marketing material and artwork; ensuring compliance to local regulations

* Review and approve claims

* Collaborate with other regions on Regulatory issues

* Proving guidance to European leadership team on regulatory opportunities and barriers

* Hiring, managing, coaching and developing direct report(s)

Quality (25%)

* Developing quality manual in line with the local Quality Management System

* Creating SOPs

* Training staff on key QMS activities

* Ensure Quality and Technical agreements are agreed with third parties

This position will also be the named EU QPPV and will have oversight of these activities, although this will not form a significant part of the role. This aspect will be heavily supported by the senior team in the UK.

Qualifications and experience:

* Degree level qualification in science or technical subject.

* Significant experience of working in a Regulatory role within either food/dietary supplements, foods, natural healthcare or OTC consumer healthcare.

* Understanding of product claims allowed for food supplements in EU.

* Good understanding of EU regulations that are relevant to products within these areas.

* Experience in working with Regulatory Authorities on product registrations, submissions and/or notifications.

* Experience working with Quality Management Systems; developing and implementing Quality and Regulatory policies and procedures to ensure compliance to applicable regulations and GxP standards.

* Detailed knowledge and practical experience of Good Manufacturing Practice

* (GMP) and Good Pharmacovigilance Practice (GPvP)

* Fluency in both written and spoken English is essential. German or French language skills would be beneficial but are not essential.

Keywords:

Regulatory, Affairs, QA, quality, QP, PV, pharmacovigilance, notified, bodies, labelling, submissions, artwork, review, QMS, management, system, SOP, GMP, GXP, GPvP, food, supplement, pharmaceutical, OTC

Harris Lord is acting as a recruitment agency for this role

Apply now