{"id":6265,"date":"2026-10-24T00:43:30","date_gmt":"2026-10-23T22:43:30","guid":{"rendered":"https:\/\/www.itcag.com\/chen\/jobs\/regulatory-specialist-clinical-or-early-stage-development-8535\/"},"modified":"2026-10-24T00:43:30","modified_gmt":"2026-10-23T22:43:30","slug":"regulatory-specialist-clinical-or-early-stage-development-6265","status":"publish","type":"wpbb_job","link":"https:\/\/www.itcag.com\/chen\/jobs\/regulatory-specialist-clinical-or-early-stage-development-6265\/","title":{"rendered":"Regulatory Specialist – Clinical or Early-Stage Development"},"content":{"rendered":"

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

\n

Background<\/strong>
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. <\/p>\n

The Perfect Candidate:<\/strong><\/p>\n

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.<\/p>\n

Tasks &; Responsibilities:<\/strong>
\uf0b7 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.
\uf0b7 CMC Lifecycle &amp; 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).
\uf0b7 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.
\uf0b7 Regulatory Compliance &amp; 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.
\uf0b7 Agency &amp; Partner Interactions: Conduct direct communications and handle routine alignment with
regulatory authorities and external partners on assigned technical matters.
\uf0b7 Operational Excellence: Proactively identify regulatory risks, optimize tracking and control systems, and
lead workflow simplification efforts to drive operational efficiency.
\uf0b7 Regulatory Intelligence: Monitor changing global regulatory guidelines and procedures, assessing potential
impacts on current product portfolios and technical strategies.<\/p>\n

Must Haves: <\/strong>
\uf0b7 Minimum Bachelor degree within a relevant field
\uf0b7 3-4 years of CMC regulatory and technical regulatory experience
\uf0b7 Fluent in verbal and written English (C1)
\uf0b7 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).
\uf0b7 Experience in CMC regulatory support for early clinical trials, IMPD preparation, and clinical regulatory
submissions.
\uf0b7 Hands-on experience with Veeva Document Management for Regulatory submission
\uf0b7 Experience with Clinical Trial Applications for early to mid stage programs<\/p>\n

Nice to Haves:<\/strong>
\uf0b7 German is a plus
\uf0b7 Prior experience at Roche is highly advantageous.
\uf0b7 Experience with Biologics desirable<\/p>\n<\/p>\n

\n

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

\n

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

<\/p>\n","protected":false},"excerpt":{"rendered":"

Regulatory Specialist – Clinical \/ Early-Stage Development (CMC Focus) : CMC \/ IMPs \/ Clinical TrialApplications (CTAs) \/ Change Control \/ Deviation Management \/Change controls \/ CMC regulatory \/ VeevaDocument Management \/ Post-Marketing \/ Remediation\/ English \/ Deutsch BackgroundA healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone hasaccess […]<\/p>\n","protected":false},"author":0,"template":"","wpbb_job_industry":[17],"wpbb_job_location":[6],"wpbb_job_type":[7],"wpbb_job_skill":[5414],"yoast_head":"\nRegulatory Specialist - Clinical or Early-Stage Development - Swiss (EN)<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.itcag.com\/chen\/jobs\/regulatory-specialist-clinical-or-early-stage-development-6265\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Specialist - Clinical or Early-Stage Development - Swiss (EN)\" \/>\n<meta property=\"og:description\" content=\"Regulatory Specialist – Clinical \/ Early-Stage Development (CMC Focus) : CMC \/ IMPs \/ Clinical TrialApplications (CTAs) \/ Change Control \/ Deviation Management \/Change controls \/ CMC regulatory \/ VeevaDocument Management \/ Post-Marketing \/ Remediation\/ English \/ Deutsch BackgroundA healthier future. 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