RAC & CMC Lead – Drug Substance (Small Molecules)

CARBOGEN AMCIS AG; Bubendorf; Ibrido; CHF 150.000 - 190.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible working time

Work from home

5 weeks vacation

Childcare contributions

Travel insurance

13th month salary

Profit-sharing bonus

Descrizione del lavoro

CARBOGEN AMCIS AG in Bubendorf, Switzerland, seeks a Manager RAC (Regulatory Affairs & CMC) to support Drug Substance CMC projects and small molecules/ADCs. You will coordinate regulatory activities from development to market launch, and provide internal/external regulatory guidance.

You will author/regulate IND/IMPD/MAA/BLA submissions, manage post-approval changes, and lead CMC regulatory gap analyses. English required; German knowledge is a plus.

Competenze

• Master/Engineering or Ph.D in Chemistry, Pharmacy or equivalent scientific discipline.
• Strong expertise in drafting IND/IMPD/MAA/BLAs from scratch; Japan accreditation is a plus.
• Good knowledge of cGMP regulations.
• Good knowledge of ICH guidelines for Small Molecules.
• At least 5 years' experience in the pharmaceutical industry/GMP environment with RA and CMC exposure.

Mansioni

• Authoring/reviewing and maintaining Drug Substance CMC modules for INDs/IMPDs/MAAs/BLAs in line with authorities and customer needs.
• Assisting with post-approval change submissions.
• CMC regulatory assessments during change management (change controls, deviations).
• Regulatory support across pre-clinical to market launch and lifecycle management.
• Regulatory review of source documents for CMC docs.
• Lead/conduct project-specific CMC regulatory gap analyses.
• Manage accreditation in Japan.
• Collaborate with health authorities/customers: briefing docs and Q&A responses.
• Provide internal regulatory advice to project teams.

Conoscenze

Regulatory Affairs

CMC development

Fluent English

German basics

Cross-functional teamwork

Formazione

Master or PhD in Chemistry/Pharmacy

Strumenti

Docubridge

eCTD

Descrizione del lavoro

CARBOGEN AMCIS AG in Bubendorf, Switzerland, seeks a Manager RAC (Regulatory Affairs & CMC) to support Drug Substance CMC projects and small molecules/ADCs. You will coordinate regulatory activities from development to market launch, and provide internal/external regulatory guidance.

You will author/regulate IND/IMPD/MAA/BLA submissions, manage post-approval changes, and lead CMC regulatory gap analyses. English required; German knowledge is a plus.