Job Description
Shape the Future of Medicine at NovaBio Therapeutics
NovaBio Therapeutics is a leading biopharmaceutical company dedicated to developing transformative therapies for oncology and rare diseases. Based in the vibrant biotech corridor of Boston, we are seeking a Senior Regulatory Affairs Specialist to lead our regulatory strategy and ensure our innovative products reach patients safely and efficiently.
In this high-impact role, you will manage the regulatory lifecycle of our clinical programs, navigating complex global frameworks to accelerate time-to-market. You will work closely with cross-functional teams to integrate regulatory intelligence into our development strategy, driving excellence in compliance and submission management.
Responsibilities
- Submission Leadership: Oversee the preparation, formatting, and submission of critical regulatory documents, including INDs, NDAs, and MAAs to the FDA and EMA.
- Regulatory Strategy: Develop and implement robust regulatory strategies that align with business objectives while ensuring full compliance with ICH guidelines and local regulations.
- Agency Liaison: Serve as the primary point of contact for regulatory agencies, responding to complex queries and managing the regulatory lifecycle from submission to approval.
- Documentation & Review: Lead the review and approval process of Clinical Study Reports (CSRs), labeling, and correspondence to maintain impeccable documentation standards.
- Compliance Monitoring: Monitor global regulatory landscapes for changes in legislation and guidelines, updating internal processes and training accordingly.
- Project Management: Coordinate with Clinical Operations and Quality Assurance to ensure regulatory requirements are embedded into project timelines and deliverables.
- Database Management: Maintain accurate records in regulatory databases and ensure the integrity of electronic submission packages (eCTD).
Qualifications
- Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, or a related Life Sciences field; a Master’s degree is strongly preferred.
- Experience: Minimum of 5-7 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Technical Expertise: Deep understanding of FDA 21 CFR Part 11, GMP, and global regulatory frameworks (FDA, EMA, PMDA).
- Technical Proficiency: Proven experience with eCTD submission software (e.g., Veeva Vault, RIM) and regulatory document management systems.
- Communication: Exceptional written and verbal communication skills with the ability to articulate complex regulatory concepts to non-technical stakeholders.
- Problem Solving: Strong analytical mindset with a track record of troubleshooting regulatory issues and driving timely resolutions.
- Regulatory Knowledge: Experience with oncology drug development and IND/CTA submissions is a significant plus.