Senior Director, Global Regulatory Strategy & Submissions

Latigo Bio; Thousand Oaks (CA); Vor Ort; USD 260.000 - 360.000; Vollzeit

Zusammenfassung

Latigo Bio is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy and execution across development programs, ensuring compliance with FDA, EMA and other authorities.

You will oversee INDs, CTAs, NDAs, and briefing documents, manage regulatory vendors, and guide cross-functional teams from discovery through commercialization. This role supports US and international filings and requires strong communication, risk management, and a track record in small molecules.

Qualifikationen

• Bachelor’s, Master’s, PharmD, or PhD in life sciences.
• Minimum of 8 years of Regulatory experience.
• Direct experience leading/supporting FDA interactions.
• Experience with IND submissions.
• US registration experience ideal.
• Experience with small molecules and pain area preferred.
• Excellent written and verbal communication skills.
• Attention to detail and strong analytical skills.

Aufgaben

• Lead regulatory strategies to support product development.
• Coordinate FDA/EMA interactions and regulatory meetings.
• Oversee IND/CTAs/NDAs submission quality.
• Ensure timely, compliant regulatory documents.
• Collaborate with Clinical, CMC, Quality, and leadership teams.
• Provide regulatory input to study designs and labeling.

Kenntnisse

Regulatory leadership

FDA interactions

US regulatory procedures

IND submission

Cross-functional collaboration

Regulatory project management

Regulatory strategy

Documentation & submissions

Attention to detail

Analytical problem-solving

Ausbildung

Bachelor's degree in life sciences

Master's degree

PharmD

PhD

Jobbeschreibung

Latigo Bio is seeking a Senior Director of Regulatory Affairs to lead regulatory strategy and execution across development programs, ensuring compliance with FDA, EMA and other authorities.

You will oversee INDs, CTAs, NDAs, and briefing documents, manage regulatory vendors, and guide cross-functional teams from discovery through commercialization. This role supports US and international filings and requires strong communication, risk management, and a track record in small molecules.