Regulatory Affairs Manager

Job Summary: 

• Develop and implement global regulatory strategies for IND/BLA applications.
• Provide regulatory guidance and scientific advice to cross-functional project team.
• Support Chief Scientific Officer in communications with regulatory authorities, including writing of meeting materials, preparation for meetings with regulatory agencies, and ensuring appropriate follow-up.

Main Job Tasks and Responsibilities:

• Develop and maintain efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.
• Monitor and maintain familiarity with evolving and/or new regulatory e-submission requirements.
• Manage all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
• Monitor and maintain the highest level of submission standards.
• Interact with regulatory agencies, coordinate the preparation of responses to questions and inquiries from FDA and other health authorities.
• Collect, review and revise study reports and documentation to ensure high-quality preparation of applications in compliance with FDA and other global health authority requirements.
• Monitor and maintain all regulatory activities to ensure compliance with relevant regulatory requirements, including but not limited to, protocol and information amendments, clinical study reports (CSRs, annual reports and safety reports to support clinical development in the US, EU, Canada, and other countries as necessary.)
• Ensure relevant US and international regulatory laws, regulations and guidance, as well as internal policies and procedures are followed to ensure regulatory compliance is maintained.

Education and Experience:

• Requires a Bachelor’s degree in life science or related discipline, Masters or PhD preferred.
• At least 3 years of regulatory affairs with experience associated with global submissions.
• Experience with the research and development of biologics/ medical devices is highly desirable.
• Experience with e-submissions desired.
• Experience working with CRO’s desired

Key Competencies:

• Working knowledge of global regulatory requirements and processes and filing experience (IND, CTA, NDA, BLA)
• Strong verbal and written communication skills are essential.
• Excellent organizational and analytical skills. Attention to detail is essential