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

If this position has piqued your interest, please send us your complete resume. If this position does not quite
match your profile and you would like to receive other positions directly, you can also send us your resume via
this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions, or our attractive payroll-only program: +41
41 760 77 01.
About us:
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult
specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and
engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we
do not charge any additional fees for payroll services.