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_1551701446
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gepubliceerd:
15 dagen geleden
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Vervaldatum:
2019-04-03
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Begin datum:
ASAP
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
*Experience with EMA and other regulatory agencies is preferred;
*Strong computer skills, project management skills, and a high attention to detail;
*Strong communication skills (both written and oral); and
*Must be a team player with a global regulatory mindset.
*This position may require supervision of junior level staff.