Job Description
Join BioPharm Innovations as a Senior Regulatory Affairs Specialist and become a pivotal player in advancing life-changing therapies. We're seeking a dynamic expert to navigate complex regulatory landscapes and accelerate our pipeline of groundbreaking pharmaceutical products. In this high-impact role, you'll collaborate with cross-functional teams to ensure compliance with FDA, EMA, and global regulatory requirements while driving strategic submissions that bring innovative treatments to market faster.
Why BioPharm Innovations? We're a globally recognized leader in biopharmaceutical R&D, committed to pushing scientific boundaries while fostering a culture of excellence and innovation. Our Boston hub offers state-of-the-art facilities, competitive benefits, and unparalleled opportunities for professional growth in one of the world's most vibrant biotech ecosystems.
Responsibilities
- Lead end-to-end regulatory strategy for new drug applications (NDAs), biologics license applications (BLAs), and marketing authorization applications (MAAs)
- Prepare, review, and submit high-quality regulatory documentation including Common Technical Documents (CTDs) and electronic submissions
- Serve as primary regulatory liaison with global health authorities (FDA, EMA, etc.) during pre-submission meetings and inspections
- Develop robust compliance programs and ensure adherence to 21 CFR Part 212 and ICH guidelines
- Maintain comprehensive regulatory intelligence on evolving policies and guidance documents
- Collaborate with R&D, clinical, and quality teams to align product development with regulatory requirements
- Manage lifecycle maintenance for marketed products including label updates and post-marketing surveillance
Qualifications
- MSc or PhD in Pharmacy, Life Sciences, or related field with 5+ years of regulatory affairs experience in pharma/biotech
- Proven expertise in US FDA and EU EMA regulatory procedures with track record of successful submissions
- Certified Regulatory Affairs Professional (RAC) credential preferred
- Deep understanding of GMP, GLP, and GCP regulations
- Exceptional written communication skills with ability to draft complex regulatory documents
- Experience managing cross-functional projects with multiple stakeholders
- Strong analytical skills and attention to detail in high-pressure environments
- Proficiency in regulatory databases and submission management systems