Regulatory Affairs Associate - Steriles - EU Generic
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Location
Essex, 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:
24015_1623163461
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Published:
about 1 year ago
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Expiry date:
2021-07-08
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Consultant:
#
Job title: Regulatory Affairs Associate - Steriles - European Generic Registration
A global pharmaceutical company in Essex are seeking an experienced regulatory affairs individual to join their EU submissions team. This role will focus on Steriles within the European markets.
Responsibilities:
- Manage new MAAs submitted via Decentralised (DCP), Mutual Recognition (MRP) and Centralised (CP) procedures.
- Work closely with line manager to coordinate preparation of high-quality dossiers, which fulfil regulatory requirements and Health Authority (HA) expectations.
- Where requested, review third party dossiers and with line manager identify risks and communicate RA input on approvability to other team members.
- Keep up to date on regulatory trends in the EU Region.
- Provide central RA support to EU countries, CA, CH and International Markets.
Requirements
- Pharmacy/Chemistry or Life Sciences degree.
- Knowledge of regulatory requirements, process, procedures, & pathways.
- Experience in Sterile/Complex Generics is essential
- Prior EU Regulatory experience would be advantageous
Salary and benefits:
A competitive annual salary and benefits scheme is on offer with this role
To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
