CMC Regulatory Specialist – Early Clinical Development (IND/IMPD)

Work Selection AG; Basel; Presencial; CHF 110 000 - 150 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Work with modern tools

Diversity and inclusion culture

Professional development support

Staff restaurant meals

On-site parking

Flexible onboarding process

Resumo da oferta

Work Selection AG is seeking a Regulatory Specialist (CMC) for a 12-month assignment in Basel, supporting Roche's early clinical development programs. The role focuses on handling Health Authority interactions, including IND, IMPD, and related CTAs, with emphasis on IMPs and early development.

You will collaborate with global teams, maintain Veeva-based CMC documentation, and drive submission readiness for clinical trials while ensuring regulatory excellence across regions.

Qualificações

• Bachelor’s degree in a relevant field.
• 3–4 years of CMC regulatory / technical regulatory experience.
• Experience with IMPs and IMPDs.
• Experience with CTAs for early- to mid-stage development programs.
• Solid hands-on experience with Veeva Document Management for regulatory submissions.
• Fluent English, written and spoken, minimum C1.

Responsabilidades

• Manage and execute global technical regulatory submissions for clinical products, ensuring regulatory compliance.
• Support CMC regulatory activities for early clinical development programs.
• Prepare and coordinate IMPDs and other technical documentation for CTAs.
• Support regulatory strategies to enable timely CTA approvals.
• Maintain CMC documentation within Veeva Document Management.
• Collaborate with global teams and stakeholders on regulatory topics.
• Support Health Authority interactions and external partners on technical topics.

Conhecimentos

CMC regulatory

Regulatory submissions

Veeva Document Management

Early clinical development

IMP/IMPD familiarity

Fluent English (C1)

Team collaboration

Formação académica

Bachelor’s degree in a relevant field

Ferramentas

Veeva Document Management

Descrição da oferta de emprego

Work Selection AG is seeking a Regulatory Specialist (CMC) for a 12-month assignment in Basel, supporting Roche's early clinical development programs. The role focuses on handling Health Authority interactions, including IND, IMPD, and related CTAs, with emphasis on IMPs and early development.

You will collaborate with global teams, maintain Veeva-based CMC documentation, and drive submission readiness for clinical trials while ensuring regulatory excellence across regions.