Associate Director, Regulatory Affairs

Scorpion Therapeutics; United States; Remote; USD 150,000 - 195,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director, Regulatory Affairs to lead global regulatory strategies for clinical trial applications, supporting biopharmaceutical programs for serious diseases. You will oversee CTAs, INDs, and CTNs across regions and coordinate with CROs and SMEs to ensure timely submissions.

The role requires 5+ years in regulatory affairs, strong project management, and fluency with regulatory interactions.

Qualifications

• Bachelor’s degree in life sciences or related field required.
• 5+ years in pharmaceutical or biotech regulatory affairs.
• Experience with global clinical trial submissions and regulatory interactions.

Responsibilities

• Oversee planning, submission, and maintenance of CTAs, INDs, and CTNs across regions.
• Ensure compliance with global regulations, ICH guidelines, and GCP.
• Coordinate with CROs, regional experts, and SMEs.
• Manage regulatory questions, amendments, and submission timelines to support clinical trial initiation and progress.

Skills

Regulatory affairs

Cross-functional collaboration

Project management

Clinical trial submissions

Education

Bachelor’s degree in life sciences

Tools

MS Office

Adobe Acrobat

Veeva Vault

Job description

Role:

Associate Director, Regulatory Affairs, leading global regulatory strategies for clinical trial applications supporting the development of biopharmaceuticals for serious diseases.

Responsibilities:

• oversee planning, submission, and maintenance of CTAs, INDs, and CTNs across regions including US, Canada, LATAM, and APAC
• ensure compliance with global regulations, ICH guidelines, and GCP
• coordinate with CROs, regional experts, and SMEs
• manage regulatory questions, amendments, and submission timelines to support clinical trial initiation and progress.

Requirements:

• Bachelor’s degree with 5+ years in pharmaceutical or biotech regulatory affairs
• experience with global clinical trial submissions and regulatory interactions
• proficiency in MS Office, Adobe, Veeva Vault
• excellent project management and cross-functional collaboration skills

Preferred:

• advanced degrees (PhD, PharmD, MD, MS).

High-Value:

• global clinical trial regulatory strategy, cross-region submission planning, agency interactions, compliance with international GxP standards.

Work setup:

fully remote with occasional domestic/international travel (~10%).