Global Regulatory Director: Strategy & Submissions

Calico Life Sciences; South San Francisco (CA); On-site; USD 275,000 - 280,000; Full time

Benefits offered by this job

Two annual cash bonuses

Job summary

Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies, ensuring compliance with health authority guidelines. The role requires collaboration with various teams, overseeing regulatory submissions, and guiding development programs.

The ideal candidate will have a Master’s degree in life sciences, at least 10 years of regulatory experience, and knowledge of FDA and EMA regulations. The estimated salary range for this role is $275,000 - $280,000 with additional bonuses.

Qualifications

• Minimum of 10 years regulatory affairs experience.
• Experience with rare disease development preferred.
• Strong knowledge of FDA and EMA regulations.

Responsibilities

• Develop worldwide regulatory strategy for assigned programs.
• Provide regulatory counsel to executive leadership.
• Lead interactions with global health agencies.
• Oversee regulatory applications submissions and ensure compliance.
• Collaborate with cross-functional teams.

Skills

Regulatory submissions

Communication skills

Strategic thinking

Problem-solving

Organizational skills

Education

Master’s degree in life sciences

PhD preferred

Job description

Calico Life Sciences is looking for a Regulatory Director in South San Francisco to develop and implement innovative regulatory strategies, ensuring compliance with health authority guidelines. The role requires collaboration with various teams, overseeing regulatory submissions, and guiding development programs.

The ideal candidate will have a Master’s degree in life sciences, at least 10 years of regulatory experience, and knowledge of FDA and EMA regulations. The estimated salary range for this role is $275,000 - $280,000 with additional bonuses.