Director, Regulatory Affairs
We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRT), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.
At Translate Bio, we’re also passionate about our five core values: Put People First, Be Approachable, Act as One, Be Tenacious, and Be Bold. These values embody our culture and underscore our mission to bring mRNA therapeutics to all.
This position serves as the regulatory lead on the project team throughout the product lifecycle. Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans to meet company objectives.
- Represent Regulatory Affairs on multi-disciplinary teams to establish and execute regulatory strategies for early and late stage development programs.
- Prepare, review and coordinate documents submitted to regulatory health authorities to assure they are complete, organized, of high quality, and compliant with applicable regional regulations.
- Oversee the preparation and completion of regulatory documents including orphan drug applications, investigational new drug applications, amendments, meeting packages, biologic license applications, IND safety reports, annual reports, and other routine regulatory submissions.
- Primary company contact with regulatory agencies.
- Works with external vendors to plan, prepare, submit, and maintain CTAs, orphan drug applications, scientific advice procedures, pediatric investigation plans, etc., in Europe, and other regions
- Review nonclinical, chemistry, manufacturing and controls, and clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidances and alignment with study objectives and regulatory strategy
- Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs
- Conducts effective and timely regulatory intelligence and research. Provides risk assessments and recommendations for various regulatory scenarios.
- Liaise externally with vendors, licensors and joint development collaborators.
- Assume additional responsibilities as assigned.
Required Skills & Qualifications
- 8-10 years of increasing global regulatory affairs experience
- Bachelor’s degree in life/health sciences field required.
- Working knowledge of US and EU regulatory requirements.
- Strong experience with FDA interactions. Experience with the EU a significant plus
- Direct hands-on experience with a variety of regulatory submissions from all phases of clinical development, INDs, CTAs, health authority meetings, BLAs etc.
- Demonstrated ability to manage multiple assignments, appropriately identify and resolve regulatory issues, and communicate as needed to management.
- Demonstrated ability to work both independently and within cross-functional teams.
- Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues
- Strong written and oral communication skills.
- 5% travel (domestic and international)
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.