Senior Regulatory Affairs Associate - EU New Submissions
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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:
25622_1633599934
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Published:
9 months ago
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Expiry date:
2021-11-06
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Consultant:
#
Job title: Senior Regulatory Affairs Associate - EU New Submissions
A global pharmaceutical company in Essex are seeking a Senior Regulatory Affairs Associate. This role will focus on new submissions of generic products in the EU.
Responsibilities:
- Manage new MAAs submitted via Decentralised (DCP) and Mutual Recognition (MRP).
- Provide central RA support to EU countries, CH and International markets
- Coordinate preparation of high-quality dossiers which fulfill regulatory requirements and Health Authority (HA) expectations.
- Keep up to date on regulatory trends, risks and opportunities in the EU Region.
- Prepare and manage the post-approval commitments and maintenance work on post-approval variations for authorised products
Requirements:
- Experience in registration of medicinal products in the EU.
- Regulatory knowledge throughout product life cycle with substantial experience with various products/devices.
- Pharmacy/Chemistry or Life Sciences degree.
- Regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities.
Salary and benefits:
A highly competitive salary, annual bonus, health insurance and wider benefits package is on offer
To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
