5 months ago
We are seeking a full-time Regulatory Affairs Associate who will work on a team to accomplish tasks and projects that are instrumental to the company's success.
*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
*Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges
*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.