A late-stage biopharmaceutical company that is on the forefront of muscle biology research is currently looking for a Regulatory Affairs Associate to join the team for a 6-month contract that has the potential of extension and conversion.
- Reviewing and assessing completeness of legacy regulatory submissions and correspondence.
- Organizing paper archives and ensuring they are also made available electronically.
- Ensuring submission and correspondence logs are updated as needed.
- Maintains current knowledge and expertise of FDA/EMA regulations and ICH guidelines
- Assists with regulatory due diligence activities
- Bachelor's degree in biology, chemistry, or related discipline
- RAC certification a plus
- 2+ years' experience in regulatory affairs or drug development preferred
- Basic knowledge of healthcare industry and strong passion for biotech
- Ability to work effectively across teams, functions and with outside partners
- Excellent oral and written communication skills
- Excellent attention to detail with solid coordinating, organization, and task planning
If interested in the Regulatory Affairs Associate position, don't hesitate apply now!