Regulatory Specialist - Clinical or Early-Stage Development

ITech Consult AG; Basel; On-site; CHF 120,000 - 180,000; Part time

Job summary

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).

Qualifications

• 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.

Responsibilities

• 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.

Skills

English (C1)

Veeva DM

CMC regulatory

Education

Bachelor degree in a relevant field

Tools

Veeva Document Management

Job description

Regulatory Specialist - Clinical or Early-Stage Development

Regulatory Specialist - Clinical / Early-Stage Development (CMC Focus) : CMC / IMPs / Clinical Trial
Applications (CTAs) / Change Control / Deviation Management /Change controls / CMC regulatory / Veeva
Document Management / Post-Marketing / Remediation/ English / Deutsch

Regulatory Specialist - Clinical / Early-Stage Development (CMC Focus) : CMC / IMPs / Clinical Trial
Applications (CTAs) / Change Control / Deviation Management /Change controls / CMC regulatory / Veeva
Document Management / Post-Marketing / Remediation/ English / Deutsch

Background

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has
access to the healthcare they need today and for generations to come. Creating a world where we all have
more time with the people we love.
That's what makes us Roche.
At Roche, we believe in empowering you to thrive and do your best work. By bringing together our unique
strengths in technical regulatory affairs, medicines, and technology, you will collaborate in an environment
that nurtures growth, values your unique perspective, and drives sustainable innovation to transform
healthcare for patients worldwide.
In the position of Regulatory Specialist (CMC) in Pharma Technical Regulatory (PTR), you will be accountable
for handling all Health Authority interactions pertaining to CMC Information (for example in an IND, IMPD and
NDA/BLA/MAA filings), as well as informational and/or pre-submission meetings with global Health
Authorities, partners and industry experts. This role requires leadership in partnering with key stakeholders,
working on both synthetic and biologic products with opportunities to work across the product lifecycle,
collaborating with affiliates, and partnering with the Policy team to influence Health Authorities.
We are currently looking for three professional Regulatory Affairs Specialists to join our team on a contract
basis. Both roles require a strong background in technical/CMC regulatory affairs and proficiency in Veeva
environments to support critical submission activities, deviation management, and change controls.

The Perfect Candidate

The perfect candidate holds a Bachelor's degree in a relevant field, C1 English fluency, and 3-4 years of
technical CMC regulatory experience either specifically focused on early clinical trials, IMPs, and Clinical Trial
Applications (CTAs) or regulatory experience managing post-approval maintenance, change controls, and
regulatory deviations. additionally, they are proficient in utilizing Veeva Document Management systems to
assemble and publish compliant regulatory submissions.

Tasks &; Responsibilities:

• Global Submission Management: Independently manage and execute global technical regulatory submissions for both clinical and commercial products, ensuring full compliance with local/regional registration requirements, internal policies, and audit standards.
• CMC Lifecycle & Change Control: Oversee the end-to-end regulatory lifecycle management of assigned products; evaluate technical change records for regulatory impact and manage the preparation and maintenance of CMC documentation in document management systems (Veeva).
• Cross-Functional Representation: Serve as the primary Pharma Technical Regulatory (PTR) representative on cross-functional project teams, offering sound regulatory advice, assessing impacts, and collaborating with diverse global stakeholders.
• Regulatory Compliance & Strategy: Partner with local and global technical teams to ensure continuous compliance. Recommend and implement effective strategies to achieve early approvals for Clinical Trial Applications (CTAs) and lifecycle extensions.
• Agency & Partner Interactions: Conduct direct communications and handle routine alignment with regulatory authorities and external partners on assigned technical matters.
• Operational Excellence: Proactively identify regulatory risks, optimize tracking and control systems, and lead workflow simplification efforts to drive operational efficiency.
• Regulatory Intelligence: Monitor changing global regulatory guidelines and procedures, assessing potential impacts on current product portfolios and technical strategies.

Must Haves

• Minimum Bachelor degree within 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

This role is focused on early clinical stage development, specifically supporting Investigational Medicinal
Products (IMPs) and Investigational Medicinal Product Dossiers (IMPDs).

• Experience in CMC regulatory support for early clinical trials, IMPD preparation, and clinical regulatory submissions.
• Hands-on experience with Veeva Document Management for Regulatory submission
• Experience with Clinical Trial Applications for early to mid stage programs

Nice to Haves

• German is a plus
• Prior experience at Roche is highly advantageous.
• Experience with Biologics desirable

Reference No.: 925346
Role: Regulatory Specialist:
Industry: Pharma
Location: Basel
Workload: 100%
Start: ASAP (01.02.2027)
Duration: 12++ Months
Deadline: 30/10/2026