Sr Scientist Product Lead CMC RA

Role:
Senior Scientist Product Lead for CMC Regulatory Affairs (Synthetic, New Modalities), focusing on global regulatory strategies and dossier preparation for innovative medicines.

Responsibilities

• develop and implement CMC regulatory plans
• contribute as the regulatory lead on project teams
• prepare and coordinate regulatory submissions for development and marketed products
• support regulatory responses and inspections
• drive continuous compliance improvements

• BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years of industry experience; advanced degrees (MS, Ph.D., Pharm.D.) preferred; strong understanding of biology, chemistry, or engineering relevant to pharma; experience in drug development, analytical development, or manufacturing; excellent communication skills and knowledge of global health authority regulations.

• expertise in CMC regulatory strategy, global filings (NDA/BLA/MAA/IND/CTA), development compounds, and lifecycle management of innovative medicines.

• multiple US locations (Pennsylvania, New Jersey); international opportunities in Beerse (Belgium) or Warsaw (Poland).
• Travel details are not specified.