Regulatory Affairs Manager
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Location
England
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Sector:
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Salary:
Negotiable
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Contact:
Denise Saab
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Contact email:
Denise.Saab@volt.eu.com
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Job ref:
73475-PHARM-DEB_1550574428
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Published:
over 5 years ago
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Expiry date:
2019-03-21
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Start date:
ASAP
We are seeking a full-time Regulatory Affairs Manager who will work on a team to accomplish tasks and projects that are instrumental to the company's success.
The company offer a fantastic package
Pension - 3% by employee, matched by employer up to 6% - 8%
25 days holiday + bank holidays and the days over Christmas.
Life Assurance x4 times base salary
Private medical insurance
Season ticket loan
Eye test contribution of up to £25, with a contribution to glasses of up to £50.
Free onsite gym between 7am - 8pm inc swimming pool.
Responsibilities
*Project management focus to facilitate full global regulatory submissions
*Providing regulatory advice and guidance to other company department to ensure compliance with EMA regulations and requirements
*Interaction with EMA and other regulatory agencies;
*Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the EMA
Qualifications
*Bachelor's degree and significant (at least 5 years' experience) regulatory affairs experience
*CMC experience preferred