Global Regulatory Strategy Director

Codera; San Diego (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

A biotech company is seeking a Director of Regulatory Affairs in San Diego, CA. The role involves developing and executing regulatory strategies, ensuring compliance with FDA and EMA requirements, and overseeing the submission of regulatory documents essential for clinical trials. Candidates should have at least 7 years of experience in regulatory affairs, outstanding communication skills, and a Bachelor’s degree. The position offers a chance to work hands-on in a fast-paced environment.

Qualifications

• 7+ years of experience in drug development and regulatory affairs.
• Experience with regulatory submissions including IND, CTA, NDA/BLA.
• Outstanding written and verbal communication skills.

Responsibilities

• Support the development and execution of regulatory strategies.
• Ensure compliance with regulatory requirements.
• Collaborate with vendors on regulatory operations.

Skills

Regulatory strategy advice

Regulatory submission documents

Communication skills

Detail-oriented

Problem analysis

Education

Bachelor’s Degree

Master’s Degree in life sciences

Job description

A biotech company is seeking a Director of Regulatory Affairs in San Diego, CA. The role involves developing and executing regulatory strategies, ensuring compliance with FDA and EMA requirements, and overseeing the submission of regulatory documents essential for clinical trials. Candidates should have at least 7 years of experience in regulatory affairs, outstanding communication skills, and a Bachelor’s degree. The position offers a chance to work hands-on in a fast-paced environment.