Senior Director, Regulatory Affairs

Scorpion Therapeutics; Gaithersburg (MD); Hybrid; USD 180,000 - 300,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Director of Regulatory Affairs to oversee global regulatory strategies for biologics development, with a focus on late-stage filings. The role is based in Gaithersburg, MD or Radnor, PA, with potential for global interaction and oversight.

You will lead IND, BLA, and sBLA submissions, develop regulatory strategies, and mentor cross-functional teams while ensuring compliance with US and international regulations.

Qualifications

• Advanced degree (MS, PharmD, PhD, or MD) with 8–12 years of experience (MS) or 10–15 years (BS).
• Extensive knowledge of US and global regulatory environments.
• Proven experience in preparing IND/CTA, BLA/NDA submissions, including at least one NME BLA/NDA.

Responsibilities

• Lead IND, BLA, and sBLA submissions.
• Develop regulatory scientific and tactical strategies.
• Liaise with FDA, EMA, MHRA and health authorities.
• Oversee regulatory documentation including CTDs, briefing documents, labeling.
• Provide leadership within cross-functional teams and mentor direct reports.
• Ensure compliance with global regulatory requirements.
• Contribute to procedures for late-stage development and commercialization.
• Manage health authority interactions and review clinical trial labeling and CMC submissions.

Skills

Regulatory submissions

Leadership

Cross-functional collaboration

Communication

Biologics

Education

Advanced degree (MS/PharmD/PhD/MD)

Job description

Role

Senior Director of Regulatory Affairs overseeing global regulatory strategies for biologics development, with a focus on late-stage filings.

Responsibilities

• lead IND, BLA, sBLA submissions
• develop regulatory scientific and tactical strategies
• liaise with FDA, EMA, MHRA
• oversee regulatory documentation including CTDs, briefing documents, labeling
• provide leadership within cross-functional development teams, including mentoring direct reports
• ensure compliance with global regulatory requirements
• contribute to procedures for late-stage development and commercialization
• manage health authority interactions and review clinical trial labeling and CMC submissions

Requirements

• advanced degree (MS, PharmD, PhD, MD) with 8-12 years' (MS) or 10-15 years' (BS) experience
• extensive knowledge of US and global regulatory environments
• proven experience in preparing IND/CTA, BLA/NDA submissions, including at least one NME BLA/NDA
• strong leadership, communication, and interpersonal skills
• experience in biologics, late-stage development, and health authority meetings

HighValue

• biologics
• late-stage development
• global regulatory submissions
• FDA interactions
• IND/BLA filings
• regulatory strategy development

WorkSetup

roles based in Gaithersburg, MD or Radnor, PA, with potential for global interaction and oversight.