Associate Director/ Regulatory Affairs
|Job Title:||Associate Director/ Regulatory Affairs|
|Contact Name:||Denise Saab|
|Job Published:||February 11, 2019 17:44|
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.
*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
*Bachelor's degree and significant (at least 8 years' experience) regulatory affairs experience;
*CMC experience preferred
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