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.
Main responsibilities:
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Project management focus to facilitate full global regulatory submissions
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Providing regulatory advice and guidance to other company department to ensure compliance with EMA regulations and requirements
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Interaction with EMA and other regulatory agencies;
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Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the EMA
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Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges
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The role would suit an individual who has experience of working in a cross-functional, global supply organisation.
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Developing, tracking, compiling, and maintaining full regulatory applications
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Providing regulatory advice and guidance to Sponsors and other company departments to ensure compliance with UK and European regulations and requirements;
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Developing scientific and regulatory briefing documents for meetings with the EMA;
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Interaction with EMA, MHRA, and other regulatory agencies;
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Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
This is an office-based position in one of the following locations: London or Munich.
Qualifications
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Bachelor's degree and significant (at least 8 years' experience) regulatory affairs experience;
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CMC experience preferred
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Experience with EMA and other regulatory agencies is preferred;
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Strong computer skills, project management skills, and a high attention to detail;
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Strong communication skills (both written and oral); and
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Must be a team player with a global regulatory mindset.
