Associate Director/ Regulatory Affairs
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plaats
London
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Sectoren:
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salaris:
Negotiable
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Contact:
Denise Saab
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Contact email:
Denise.Saab@volt.eu.com
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functie ref:
73476-PHARM-DEB_1550574469
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gepubliceerd:
ongeveer 5 jaar geleden
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Vervaldatum:
2019-03-21
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Begin datum:
ASAP
We are seeking a full-time Regulatory Affairs Associate Director 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% for managers
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 8 years' experience) regulatory affairs experience;
*CMC experience preferred