Regulatory Specialist (CMC) — Early Clinical & IMPD Submissions

ITech Consult AG

Basel

In loco

CHF 120.000 - 180.000

Part-time

2 giorni fa

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Descrizione del lavoro

Roche Basel seeks a Regulatory Specialist (CMC) focused on Clinical/Early-Stage Development to lead global technical regulatory submissions (IND/IMPD/CTAs) and manage change controls in Veeva environments. The role requires collaboration with PTR, affiliates, and external partners across the product lifecycle.

The ideal candidate has a Bachelor in a relevant field, 3–4 years in CMC regulatory work, and fluent English (C1).

Competenze

Bachelor degree in a relevant field.
3-4 years of CMC regulatory and technical regulatory experience.
Fluent in English (C1).
Solid knowledge of Veeva and Veeva Document Management for Regulatory submissions.

Mansioni

Global Submission Management: Independently manage and execute global technical regulatory submissions for both clinical and commercial products.
CMC Lifecycle & Change Control: Oversee end-to-end regulatory lifecycle management and maintain CMC documentation in Veeva.
Cross-Functional Representation: Serve as PTR representative on cross-functional project teams and advise on regulatory impacts.
Regulatory Compliance & Strategy: Collaborate with local/global teams to ensure ongoing compliance and pursue early CTA approvals.
Agency & Partner Interactions: Communicate with regulatory authorities and external partners on technical matters.
Operational Excellence: Identify regulatory risks and optimize tracking and workflow efficiency.
Regulatory Intelligence: Monitor changes in global guidelines and assess impacts on portfolios.