CMC Regulatory Affairs Manager – Hybrid, San Francisco

Barrington James; San Francisco (CA); Hybrid; USD 130,000 - 160,000; Full time

Benefits offered by this job

Opportunity to join a global organization

Exposure to U.S. and global regulatory submissions

Work directly with experienced regulatory leadership

Hybrid or onsite working model

Job summary

A well-established global pharmaceutical company is seeking a Regulatory Affairs Manager CMC for its San Francisco team. This role involves developing CMC regulatory strategies and managing submissions like INDs and NDAs, ensuring compliance with regulatory authorities. The position offers exposure to both U.S. and global regulatory processes while working with experienced leadership. A hybrid or onsite working model is available, making it an exciting opportunity to contribute to the company's growth in the pharmaceutical division.

Qualifications

• 7+ years of experience in Regulatory Affairs, focusing on CMC.
• Experience with U.S. and global regulatory filings.
• Ability to work with cross-functional teams.

Responsibilities

• Develop and execute CMC regulatory strategies.
• Prepare and manage regulatory submissions including INDs, NDAs, and BLAs.
• Collaborate with teams to ensure submission alignment.
• Provide regulatory guidance during product development.

Skills

Regulatory Affairs experience

CMC development

Strong understanding of regulatory requirements

Experience with IND, NDA, BLA submissions

Cross-functional collaboration

Education

Bachelor’s or advanced degree in a relevant scientific discipline

Job description

A well-established global pharmaceutical company is seeking a Regulatory Affairs Manager CMC for its San Francisco team. This role involves developing CMC regulatory strategies and managing submissions like INDs and NDAs, ensuring compliance with regulatory authorities. The position offers exposure to both U.S. and global regulatory processes while working with experienced leadership. A hybrid or onsite working model is available, making it an exciting opportunity to contribute to the company's growth in the pharmaceutical division.