Regulatory Affairs Specialist

Scorpion Therapeutics; Indiana (PA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Regulatory Affairs Specialist to support global and regional regulatory strategies across product lifecycle stages in biopharma. You will prepare and review submissions, collaborate with Medical Writing, CMC, and Clinical Ops, and aid health authority interactions.

In this hybrid role based in Indianapolis, IN, you will help ensure post‑marketing compliance, maintain regulatory documentation, and drive lifecycle management while communicating complex scientific

Qualifications

• Bachelor’s degree in a scientific/healthcare field required.
• Minimum 3 years regulatory experience in biopharma or CROs.
• Hands-on experience with US FDA submissions, eCTD, and 21 CFR regulations.
• Familiarity with GxP and ICH guidelines.
• Proficiency with document management systems such as Veeva Vault RIM.

Responsibilities

• Prepare and review regulatory submissions (INDs, NDAs, BLAs, safety reports) in eCTD format.
• Collaborate with cross-functional teams (Medical Writing, CMC, Clinical Ops).
• Support health authority interactions, including briefing packages and IR responses.
• Ensure compliance in post-marketing activities like labeling and manufacturing updates.
• Maintain regulatory documentation and databases.

Skills

Regulatory affairs

Cross-functional collaboration

Scientific writing

Project management

US FDA submissions (IND/NDAs/BLA)

GxP and ICH familiarity

eCTD experience

Education

Bachelor’s in a scientific/healthcare field

Tools

Veeva Vault RIM

Job description

Role

Regulatory Affairs Specialist supporting global and regional regulatory strategies across product lifecycle stages in biopharma.

Responsibilities

• prepare and review regulatory submissions (INDs, NDAs, BLAs, safety reports) in eCTD format;
• collaborate with cross-functional teams (Medical Writing, CMC, Clinical Ops);
• support health authority interactions, including briefing packages and IR responses;
• ensure compliance in post-marketing activities like labeling and manufacturing updates;
• maintain regulatory documentation and databases.

Requirements

• Bachelor’s in a scientific/healthcare field;
• minimum 3 years’ regulatory experience in biopharma or CROs;
• hands‑on experience with US FDA submissions, eCTD, and 21 CFR regulations;
• familiarity with GxP and ICH guidelines;
• proficiency with document management systems such as Veeva Vault RIM;
• strong scientific writing and project management skills.

Preferred

• RAC certification.

HighValue

• US FDA regulatory expertise, experience with IND/NDA/BLA submissions, cross‑functional collaboration, lifecycle management, and compliance in an FDA-regulated environment.

WorkSetup

hybrid in Indianapolis, IN; flexible work arrangements.