Reporting to the Senior Director of Regulatory Affairs, the Senior Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects.

Responsibilities

• Prepare and/or coordinate and comply routine regulatory submissions and other correspondence in accordance with regulatory agency regulations and guidelines
• Review regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements
• Interface with functional areas (CMC, Nonclinical, Clinical) to obtain information required for regulatory submissions
• Assist with creating and maintaining regulatory timelines and tracking deliverables to ensure regulatory submission timelines are met
• Assist with preparation for global regulatory team and subteam meetings
• Develop and maintain tracking logs for regulatory activities
• Monitor regulatory environment for changes to requirements
• Support regulatory team through research on evolving regulatory issues, overall product landscape, etc, including searches of the relevant literature
• Maintain current knowledge and expertise of FDA/EMA regulations and ICH guidelines
• Collaborate with other functional areas in preparing and maintaining SOPs and appropriate regulatory operating guidelines
• Assist with regulatory due diligence and inspection readiness activities

Qualifications

• Bachelor’s degree in biology, chemistry, or related discipline with 2 years’ experience in regulatory affairs or drug development preferred
• RAC certification a plus
• Ability to work effectively across teams, functions and with outside partners
• Ability to prioritize and handle multiple competing tasks
• Excellent oral and written communication skills
• Excellent attention to detail with solid coordinating, task planning and time management skills