Regulatory Affairs Manager
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Location
Hertfordshire, England
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Sector:
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Job type:
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Salary:
Negotiable
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Contact:
Matt Thomas
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Contact email:
matt.thomas@pharma-partners.co.uk
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Job ref:
18238_1576658830
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Published:
over 2 years ago
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Expiry date:
2019-12-17
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Consultant:
#
Job title: Regulatory Affairs Manager
An independent Pharmaceutical/Medical Device business with portfolios in Aesthetics and Neuroscience is seeking a Regulatory Affairs Manager. This role will cover a wide variety of regulatory activities with close interaction with the MHRA and HPRA.
Responsibilities:
- Preparation, maintenance and review of Product Information
- Raisin CAPAs and deviations as necessary
- Management of MPUK and Global (when relevant) POLs/SOPs/WIs
- Manage the life-cycle maintenance of existing MAs
- Working with cross-functional groups to guarantee the development of regulatory strategies match business goals
- Managements on EQMS including the management of training modules
Requirements:
- A minimum of 3 years' experience within Regulatory Affairs
- Highly experienced in filing variations with the MHRA with additional knowledge of eCTD, publishing and electronic portals
- Life sciences degree as a minimum. Pharmacy degree is desirable
- Extensive experience within Medical Devices is desirable
Remuneration:
- Competitive basic annual salary plus a benefits package to include annual bonus
To apply for this position please use the "Easy Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk
