Regulatory Specialist / Regulatory Specialist

Regulatory Specialist

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, housing important research and development functions. We are currently seeking a Regulatory Specialist to join our long-term client, F. Hoffmann-La Roche AG, in Basel.

Background

At Roche, we believe in empowering our team to thrive and do their best work. By leveraging our unique strengths in technical regulatory affairs, medicines, and technology, you will collaborate in an environment that nurtures growth, values diverse perspectives, and drives sustainable innovation to transform healthcare for patients worldwide.

Position Overview

As a Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR), you will be responsible for managing all Health Authority interactions related to Chemistry, Manufacturing, and Controls (CMC) Information for clinical and commercial submissions, as well as conducting informational and pre-submission meetings with global Health Authorities, partners, and industry experts. This role requires strong leadership and collaboration with key stakeholders, working with both synthetic and biologic products across the product lifecycle while partnering with the Policy team to influence Health Authorities.

Roles Available

• Regulatory Specialist -- Clinical / Early-Stage Development (CMC Focus)
  Focused on early clinical stage development, this role supports Investigational Medicinal Products (IMPs) and Investigational Medicinal Product Dossiers (IMPDs). Responsibilities include CMC regulatory support for early clinical trials and preparing clinical regulatory submissions.
• Regulatory Specialist -- Commercial / Post-Marketing & Remediation
  Involves working with commercialized products, emphasizing post-approval regulatory maintenance and managing regulatory deviations. Experience in change controls and legacy data clean-up is essential.

Key Responsibilities

• Global Submission Management: Independently manage and execute global technical regulatory submissions while ensuring compliance with registration requirements and internal policies.
• CMC Lifecycle & Change Control: Oversee the end-to-end regulatory lifecycle management of assigned products, evaluating technical changes for regulatory impact.
• Cross-Functional Representation: Act as the primary PTR representative on project teams, providing regulatory guidance and collaborating with global stakeholders.
• Regulatory Compliance & Strategy: Partner with technical teams to ensure continuous compliance and recommend strategies to achieve early approvals for Clinical Trial Applications (CTAs).
• Agency & Partner Interactions: Conduct communications and alignments with regulatory authorities and external partners on technical matters.
• Operational Excellence: Identify regulatory risks and lead workflow simplification efforts to optimize efficiency.
• Regulatory Intelligence: Monitor global regulatory changes and assess their impact on product portfolios and technical strategies.

Qualifications

• Minimum Bachelor's degree in a relevant field
• 3-4 years of CMC regulatory and technical regulatory experience
• Fluent in verbal and written English (C1)
• Solid knowledge of Veeva and Veeva Document Management for regulatory submissions

Desirable Skills

• German language proficiency is a plus
• Prior experience at Roche is highly advantageous
• Experience with Biologics preferred

What We Offer

• An opportunity to work in one of the world's leading pharmaceutical companies
• A modern campus with ample green spaces and meeting areas
• Central location in Basel
• A varied job profile
• Further training opportunities
• Collaborating within a dynamic and motivated team

If you are interested, please apply online using the form below. Only applications matching the job profile will be considered.