Our client is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. They are continuing to expand their commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage their unique expertise.
The therapeutic areas of focus include sleep and hematology/oncology – areas in which they have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
Seeking a regulatory affairs manager to support the Sleep/CNS product portfolio. The manager will be responsible for ensuring activities needed to maintain registration in the US are complete, support EU/ROW registration activities and provide regulatory support for ongoing development activities for the product.
- Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products and late stage and early development programs. Identify and communicate potential risks associated with regulatory strategies
- Represent Regulatory Affairs as a team member, covering clinical and general regulatory activities
- Provide in depth review of protocols, reports, presentations and other documents
- Document regulatory activities with FDA and other Health Authorities
- Prepare IND and NDA submissions, including clinical trial applications, amendments, periodic safety updates, supplements, meeting requests, briefing packages, annual reports, etc. Assist in managing internal review and submission of these items.
- Ensure consistency, completeness, accuracy and adherence to regulations and applicable guidelines for all regulatory submissions
Required Knowledge, Skills, and Abilities:
- Five years of regulatory experience
- Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA stages
- Solid understanding of and experience with electronic common technical document (eCTD) submissions with ability to create content.
- Excellent written and verbal communication skills
- Ability to work effectively in cross-functional teams
- Excellent organizational and time management skills, ability to manage multiple complex projects
- Travel up to 10%-20% of the time
Required/Preferred Education and Licenses
- BS/BA with a minimum of five years of regulatory experience