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Regulatory Specialist - Clinical / Early-Stage Development – Basel | JobRevolt

Über den Job

As a first-tier supplier to a renowned business partner F.-La Ltd. in Basel, you will work as a Regulatory Specialist (CMC) for early clinical development programs. This 12-month temporary assignment involves managing Health Authority interactions pertaining to CMC information, including IND, IMPD and clinical regulatory submissions. You will collaborate with global stakeholders in an innovative environment focused on early investigational medicinal products (IMPs) and clinical trial applications.

Aufgaben

Independently manage and execute global technical regulatory submissions for clinical products, ensuring compliance with local and regional registration requirements, internal policies and audit standards
Support CMC regulatory activities for early clinical development programs
Prepare and coordinate IMPDs and other technical documentation required for Clinical Trial Applications
Support regulatory strategies aimed at enabling timely approval of CTAs
Evaluate technical information and changes for potential regulatory impact
Maintain CMC documentation within Veeva Document Management
Represent Pharma Technical Regulatory on cross-functional project teams and provide regulatory advice
Collaborate with global technical teams, affiliates and other stakeholders
Support interactions with Health Authorities and external partners on assigned technical topics
Identify regulatory risks and support improvements to submission processes and workflows
Monitor relevant changes in global regulatory requirements and assess their potential impact on development programs

Profil

Minimum Bachelor's degree in a relevant field
3-4 years of CMC regulatory/technical regulatory experience
Experience in CMC regulatory support for early clinical trials
Experience with Investigational Medicinal Products (IMPs)
Hands-on experience preparing or supporting Investigational Medicinal Product Dossiers (IMPDs)
Experience with Clinical Trial Applications 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
French language skills preferred
Experience with biologics preferred

Rahmenbedingungen

Arbeitsort: Basel
Pensum: 100%
Befristung: 12 Monate
Position: Mitarbeiter
Branche: Pharma + Chemie + Life Science
Interessiert? Submit your complete application documents online today

Benefits

Work with modern and up-to-date tools in an innovative work environment
Work culture that promotes diversity and inclusion
Financial support for professional development plans
Discounts at over 200 renowned retailers and top brands
Fleet discounts when purchasing new cars or fuel card discounts
State-of-the-art campus with green spaces and meeting areas
Fitness and swimming pool facilities, gaming room
High-quality meals in modern staff restaurants
On-site parking spaces available
Professional onboarding process and Welcome Days

Regulatory Specialist - Clinical / Early-Stage Development

Über den Job

Über den Job

Aufgaben

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Rahmenbedingungen

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