RAC & CMC Manager - Small Molecules | Remote & Flexible Hours

Carbogen Amcis; Bubendorf; Hybrid; CHF 120,000 - 160,000; Full time

Benefits offered by this job

13th month salary

Profit-sharing bonus

5 weeks vacation or more

Childcare contribution

Private accident insurance

Travel insurance for private trips

Job summary

CARBOGEN AMCIS in Bubendorf, Switzerland, seeks a Manager RAC (Regulatory Affairs & CMC) to join the corporate RAC and local Swiss team. You will manage regulatory activities for Drug Substance projects, including CMC for small molecules and ADCs, from development to market launch and lifecycle.

You will coordinate submissions, provide regulatory advice, and drive CMC development with cross-functional teams, including global health authorities and customers.

Qualifications

• Master/Ph.D in Chemistry, Pharmacy or equivalent.
• Strong regulatory affairs expertise for Drug Substance with CMC focus.
• Drafting IND/IMPD/MAA regulatory files from scratch.
• Good knowledge of cGMP and ICH guidelines for small molecules.
• 5+ years in pharma/GMP with regulatory affairs and CMC exposure.
• Fluency in English; basic German recommended.

Responsibilities

• Authoring, reviewing and maintaining Drug Substance CMC documents for registrations.
• Assist with post-approval change submissions.
• Regulatory assessment for change control and deviations.
• CMC regulatory support across preclinical to market launch and lifecycle.
• Regulatory review of source documents for CMC documentation.
• Lead or conduct CMC regulatory gap analyses for small molecules.
• Coordinate with Health Authorities and customers on filings.
• Provide regulatory advisory support to internal teams and projects.

Skills

Regulatory Affairs

CMC development

IND/IMPD/MAA/BLAs drafting

ICH guidelines

GMP/cGMP knowledge

English fluency

Regulatory project coordination

eCTD submission software (Docubridge)

Education

Master / Engineering or Ph.D in Chemistry/Pharmacy

Tools

Docubridge

eCTD submission

Job description

CARBOGEN AMCIS in Bubendorf, Switzerland, seeks a Manager RAC (Regulatory Affairs & CMC) to join the corporate RAC and local Swiss team. You will manage regulatory activities for Drug Substance projects, including CMC for small molecules and ADCs, from development to market launch and lifecycle.

You will coordinate submissions, provide regulatory advice, and drive CMC development with cross-functional teams, including global health authorities and customers.