Job Description
Join BioPharm Innovations, a leader in cutting-edge pharmaceutical research, as we revolutionize patient care through groundbreaking therapies. We're seeking a dynamic Senior Regulatory Affairs Specialist to navigate the complex landscape of global pharmaceutical compliance and drive our product lifecycle strategies. This pivotal role offers the opportunity to shape regulatory frameworks while advancing life-changing treatments. Our collaborative, innovation-driven environment empowers you to make a tangible impact on global health standards.
Responsibilities
- Develop and execute global regulatory strategies for novel therapeutics, ensuring compliance with FDA, EMA, and ICH guidelines
- Prepare and submit regulatory dossiers (CTDs, eCTD) for NDA/BLA approvals and lifecycle management
- Lead cross-functional teams in regulatory risk assessment and compliance initiatives
- Monitor and interpret evolving regulatory landscapes, providing strategic guidance to leadership
- Manage interactions with health authorities during clinical trials and post-marketing surveillance
- Coordinate global submissions across multiple markets while maintaining quality standards
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field with 5+ years regulatory affairs experience
- Proven track record in FDA/EMA submissions for biologics or small molecules
- Expertise in GMP, GLP, and pharmacovigilance regulations
- Strong project management skills with ability to manage complex global timelines
- Certification in Regulatory Affairs (RAC) preferred
- Exceptional written communication skills for technical documentation
- Experience with electronic submission systems (e.g., Veeva Vault RIM)