Job Description
Join BioPharm Innovations, a leader in cutting-edge pharmaceutical research, as we revolutionize global healthcare solutions. We're seeking a dynamic Senior Regulatory Affairs Specialist to navigate complex regulatory landscapes and accelerate our life-changing therapies to market. In this pivotal role, you'll shape regulatory strategies for novel drug formulations while ensuring compliance with FDA, EMA, and international standards. Our collaborative culture empowers you to make tangible impacts on patient lives while advancing your career in one of the world's most innovative biotech hubs.
Responsibilities
- Develop and execute comprehensive regulatory strategies for new pharmaceutical products across global markets
- Prepare and submit regulatory dossiers (INDs, NDAs, MAAs) while ensuring adherence to ICH guidelines
- Act as primary liaison with FDA, EMA, and other health authorities during review cycles
- Manage product lifecycle compliance from preclinical through post-marketing surveillance
- Lead cross-functional teams to integrate regulatory requirements into development plans
- Monitor evolving regulations and provide strategic guidance to R&D and clinical operations
- Maintain electronic regulatory submission systems (e.g., RPS, Veeva Vault)
Qualifications
- Advanced degree (PharmD, MS, or PhD) in Pharmacy, Life Sciences, or related field
- 5+ years of progressive regulatory affairs experience in pharmaceutical/biotech industry
- Demonstrated success with FDA/EMA submissions and health authority interactions
- Expertise in GMP, GLP, and global regulatory frameworks (ICH, EU, FDA)
- Strong project management skills with ability to manage complex timelines
- Certified Regulatory Affairs Professional (RAC) preferred
- Excellent written/verbal communication and negotiation abilities
- Experience with biologics, small molecules, or advanced therapy medicinal products