Senior CMC Regulatory Lead – Biologics (Remote)

Travere Therapeutics; San Diego (CA); Hybrid; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

Generous paid time off

Retirement plans with employer match

Job summary

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs, based in San Diego with a focus on leading global regulatory strategies for biologics development. This role requires strong experience in CMC regulatory work, collaboration across functional teams, and a passion for supporting innovative therapies for rare diseases.

The selected candidate will be responsible for managing regulatory submissions and ensuring alignment with global regulatory requirements. A Bachelor's degree in a scientific field and extensive Regulatory Affairs experience are essential.

Qualifications

• 7+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience supporting biologics development programs from early development through commercialization.
• Extensive experience leading CMC regulatory activities for biologic products.

Responsibilities

• Lead the development and execution of global CMC regulatory strategies.
• Drive CMC regulatory submissions and manage Health Authority interactions.
• Ensure compliance with global regulatory requirements and submission standards.

Skills

Regulatory Affairs experience

Biologics development knowledge

CMC regulatory strategies

Cross-functional teamwork

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PharmD, PhD)

Job description

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs, based in San Diego with a focus on leading global regulatory strategies for biologics development. This role requires strong experience in CMC regulatory work, collaboration across functional teams, and a passion for supporting innovative therapies for rare diseases.

The selected candidate will be responsible for managing regulatory submissions and ensuring alignment with global regulatory requirements. A Bachelor's degree in a scientific field and extensive Regulatory Affairs experience are essential.