Senior Manager, Regulatory Affairs
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Location
Berkshire, England
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Sector:
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Job type:
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Salary:
Up to £80000 per annum
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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:
19537_1579098296
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Published:
over 2 years ago
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Expiry date:
2020-02-14
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Consultant:
#
Job title: Senior Manager, Regulatory Affairs
A specialist, global pharmaceutical company in Berkshire are seeking a Senior Manager, Regulatory Affairs to lead and manage the Regulatory function. This opportunity will have overall responsibility for all regulatory activities across the EU and other markets.
Responsibilities:
- Development of regulatory strategies to ensure timely approval from various regulatory bodies
- Management of registration dossiers and submissions of MAA's across multiple territories
- Cross functional interaction with commercial, medical information, medical affairs and pharmacovigilance teams
- Leadership and training of employees within the regulatory affairs team
- Lead interactions with regulatory bodies such as the EMEA and MHRA
- Maintenance of labelling and product information to ensure compliance within guidelines
Requirements:
- Extensive experience within the Pharmaceutical industry, Medical Device experience is desirable
- Full product life cycle experience is essential - key focus on post approval
- Experience of working with Regulatory bodies such as the EMEA and MHRA. Middle East and Australia/New Zealand would be a bonus
- Previous experience of managing a product through the DCP/MRP/National approval process
- Previous line management experience is essential
- Life Science degree
Salary and benefits:
- Competitive annual salary
- Car allowance
- Performance related annual bonus
- Private medical insurance
- Income protection
- Life assurance
To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk
