Sr Scientist Product Lead CMC RA

Scorpion Therapeutics; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Scientist Product Lead for CMC Regulatory Affairs (Synthetic, New Modalities) to drive global regulatory strategies and dossier preparation for innovative medicines.

You will lead CMC regulatory plans, coordinate submissions for development and marketed products, and support responses and inspections while advancing compliance across programs.

Qualifications

• 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 and knowledge of global health authority regulations.

Responsibilities

• Develop and implement CMC regulatory plans.
• Serve as regulatory lead on project teams.
• Prepare and coordinate regulatory submissions for development and marketed products.
• Support regulatory responses and inspections.
• Drive continuous compliance improvements.

Skills

Regulatory affairs experience

CMC regulatory strategy

Global filings knowledge

Excellent communication skills

Drug development experience

Analytical development knowledge

Education

BS in biological/pharmaceutical/chemical/engineering sciences

MS/PhD/PharmD preferred

Job description

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

Requirements

• 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.

HighValue

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

WorkSetup

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