CMC Regulatory Specialist - Clinical/Early-Stage (Imps)

Work Selection AG; Basel; On-site; CHF 110,000 - 140,000; Full time

Benefits offered by this job

Modern tools & platforms

Diversity & inclusion culture

Professional development support

Staff restaurants

Job summary

Work Selection AG in Basel is seeking a Regulatory Specialist (CMC) for a 12-month temporary assignment. You will handle Health Authority interactions for CMC information, including IND, IMPD, and CTAs, with a focus on early clinical development and IMP support.

Strong regulatory expertise, collaboration with global teams, and Veeva DMS proficiency are required. English must be fluent (C1). German skills are a plus.

Qualifications

• Minimum Bachelor's degree in a relevant field.
• 3-4 years of CMC regulatory/technical regulatory experience.
• Experience supporting early clinical trials and IMPs.
• Hands-on with IMPDs and CTAs.
• Fluent English, written and spoken (C1).

Responsibilities

• Manage global technical regulatory submissions for clinical products.
• Support CMC activities for early clinical development programs.
• Prepare IMPDs and other regulatory technical documentation.
• Assist in regulatory strategies for timely CTAs approvals.
• Maintain CMC documentation in Veeva DMS and govern submissions.
• Collaborate with global teams and Health Authorities on topics.

Skills

CMC regulatory

Regulatory submissions

Veeva DMS

English proficiency (C1)

Education

Bachelor's degree in a relevant field

Tools

Veeva Document Management

Job description

Work Selection AG in Basel is seeking a Regulatory Specialist (CMC) for a 12-month temporary assignment. You will handle Health Authority interactions for CMC information, including IND, IMPD, and CTAs, with a focus on early clinical development and IMP support.

Strong regulatory expertise, collaboration with global teams, and Veeva DMS proficiency are required. English must be fluent (C1). German skills are a plus.