Senior Specialist, Regulatory Affairs

Scorpion Therapeutics; Summit (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics in Summit, New Jersey, seeks a Senior Specialist in Regulatory Affairs to provide expertise in regulatory compliance strategies for biopharma products. The role is full-time and desk-based, collaborating with scientific and regulatory teams to drive roadmap submissions.

Responsibilities include developing and reviewing regulatory documents, ensuring compliance with FDA and ICH guidelines, and monitoring evolving regulations to align with global submissions for marketed and

Qualifications

• Bachelor's or Master’s in life sciences with 7+ years regulatory compliance experience.
• Experience with US and international submissions preferred.

Responsibilities

• develop and review regulatory documents (CTDs)
• ensure compliance with US and international health authority requirements
• assist in regulatory strategy development
• monitor evolving regulations

Skills

FDA/ICH guidelines

Project management

Document organization

Effective communication

Education

Bachelor's or Master's in life sciences

Job description

Role:

Senior Specialist, Regulatory Affairs, providing expertise in regulatory compliance strategies for biopharma products.

Responsibilities:

• develop and review regulatory documents (CTDs)
• ensure compliance with US and international health authority requirements
• assist in regulatory strategy development
• monitor evolving regulations

Qualifications:

• Bachelor's or Master’s in life sciences, with 7+ or 5+ years of regulatory compliance experience in pharmaceutical drug development; experience with US and international submissions preferred.

Skills:

• strong knowledge of FDA, ICH guidelines, project management, document organization, and effective communication.

High-Value:

• focus on immunotherapies, cell therapies, or biologics in development stages, with experience in regulatory submissions and compliance for marketed and pipeline products.

Collaboration:

Collaboration with scientific and regulatory teams.

Work setup:

Work setup: full-time, predominantly desk-based; no specific travel requirements stated.