Senior Director, Regulatory Affairs CMC

Scorpion Therapeutics; Conshohocken (Montgomery County); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Director of Regulatory Affairs CMC to provide strategic and operational leadership for regulatory chemistry, manufacturing, and controls activities supporting clinical trials, market registrations, and post-approval submissions for biopharmaceutical products.

Based in a hybrid setting in the US, the role will drive regulatory strategies across the product lifecycle, coordinate dossier content, and represent the company in global health authority meetings,

Qualifications

• BS in life sciences or healthcare with 15+ years of regulatory CMC experience.
• Global CMC development, clinical trial and commercialization support, particularly for small molecule products.
• Strong regulatory authority interaction experience.

Responsibilities

• Develop and execute regulatory CMC strategies across product lifecycle.
• Oversee regulatory dossier content and ensure compliance with health authority requirements.
• Serve as the company’s representative in global health authority meetings.
• Support quality activities, inspections, and change management.
• Identify and mitigate regulatory risks, and stay current with evolving global regulatory guidance.

Skills

Regulatory CMC experience

Global regulatory interaction

Regulatory strategy

Education

BS in life sciences

Job description

Role

Senior Director of Regulatory Affairs CMC, providing strategic and operational leadership for regulatory chemistry, manufacturing, and controls activities supporting clinical trials, market registration, and post-approval submissions for biopharmaceutical products.

Responsibilities

• develop and execute regulatory CMC strategies across product lifecycle
• oversee regulatory dossier content and ensure compliance with health authority requirements
• serve as the company’s representative in global health authority meetings
• support quality activities, inspections, and change management
• identify and mitigate regulatory risks, and stay current with evolving global regulatory guidance

Qualifications

• BS in life sciences or healthcare, with 15+ years’ regulatory CMC experience
• proven expertise in global CMC development, clinical trial and commercialization support, particularly for small molecule products
• strong regulatory authority interaction experience
• excellent communication and negotiation skills

HighValue

• extensive global CMC regulatory experience, including interactions with health authorities, regulatory dossier preparation, and lifecycle management
• focus on small molecule pharmaceuticals
• involvement in regulated environments with a deep understanding of regulatory guidelines

WorkSetup

hybrid model based in Waltham, MA or Conshohocken, PA, with a 3-day in-office requirement.