Senior Regulatory CMC Manager — Vaccines (Remote)

Vaxcyte, Inc; San Carlos (CA); On-site; USD 183,000 - 194,000; Full time

Benefits offered by this job

Comprehensive benefits

Equity component

Job summary

Vaxcyte, Inc is seeking a hands-on Regulatory CMC specialist to develop multi-product global regulatory strategies. This critical role involves managing regulatory submissions and ensuring compliance with Health Authorities. Candidates should have a Bachelor’s in a scientific field and over 9 years of experience in the vaccine or biotech industry.

The position allows for remote work and offers a competitive compensation package, including benefits and equity. Join our mission to innovate life-saving vaccines.

Qualifications

• 9+ years of experience in the vaccine or biotech industry.
• Experience preparing/authoring CMC DS sections for BLA and IND.
• Ability to manage multiple deadlines with high accuracy.

Responsibilities

• Develop and execute global regulatory CMC strategies.
• Prepare regulatory CMC submissions and responses.
• Manage documentation and interactions with Health Authorities.

Skills

Regulatory CMC guidance

Cross-functional collaboration

Project management

Change control review

Software proficiency (LIMS, SAP, Veeva)

Education

Bachelor of Science in a scientific discipline

Tools

LIMS

SAP

TrackWise

Veeva

Job description

Vaxcyte, Inc is seeking a hands-on Regulatory CMC specialist to develop multi-product global regulatory strategies. This critical role involves managing regulatory submissions and ensuring compliance with Health Authorities. Candidates should have a Bachelor’s in a scientific field and over 9 years of experience in the vaccine or biotech industry.

The position allows for remote work and offers a competitive compensation package, including benefits and equity. Join our mission to innovate life-saving vaccines.