CMC Regulatory Manager - Small Molecules, Flexible/Remote

CARBOGEN AMCIS AG; Bubendorf; Hybrid; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Flexible working time

Home office possibility

5 weeks vacation

Childcare contribution

Travel insurance

Profit-sharing bonus

13th month salary

Job summary

CARBOGEN AMCIS AG in Switzerland seeks a Manager RAC to lead Regulatory Affairs & CMC for Drug Substance projects, focusing on small molecules and ADCs. You will coordinate with global teams to prepare IND/IMPD/MAA/BLAs, ensuring compliance and timely submissions across development stages.

The role requires 5+ years in pharma regulatory affairs with CMC depth, strong communication, and project leadership skills. Hybrid work model, generous vacation, and robust benefits offered.

Qualifications

• Master or PhD in chemistry, pharmacy, or equivalent.
• 5+ years in regulatory affairs with CMC focus for small molecules.
• Experience with IND/IMPD/MAA/BLAs and regulatory submissions.
• Knowledge of cGMP and ICH guidelines; English fluent.

Responsibilities

• Authoring and reviewing registration documents for regulatory submissions.
• Lead CMC regulatory activities from preclinical to market launch.
• Coordinate with Health Authorities and customers; support change management.
• Regulatory gap analyses and project-specific regulatory strategy.
• Manage training and collaboration across departments.

Skills

Regulatory affairs

CMC development

Project management

English fluency

GMP knowledge

Education

Master's degree in Chemistry

PhD in Chemistry or Pharmacy

Tools

Docubridge

Job description

CARBOGEN AMCIS AG in Switzerland seeks a Manager RAC to lead Regulatory Affairs & CMC for Drug Substance projects, focusing on small molecules and ADCs. You will coordinate with global teams to prepare IND/IMPD/MAA/BLAs, ensuring compliance and timely submissions across development stages.

The role requires 5+ years in pharma regulatory affairs with CMC depth, strong communication, and project leadership skills. Hybrid work model, generous vacation, and robust benefits offered.