Regulatory Specialist - Commercial/Post-Marketing & Remediation

Regulatory Specialist - Commercial / Post-Marketing \& Remediation :CMC / IMPs / Clinical Trial Applications (CTAs) / Change Control / Deviation Management /Change controls / CMC regulatory / Veeva Document Management / Post-Marketing / Remediation/English

Regulatory Specialist - Commercial/Post-Marketing \& Remediation

Regulatory Specialist - Commercial / Post-Marketing \& Remediation :CMC / IMPs / Clinical Trial Applications (CTAs) / Change Control / Deviation Management /Change controls / CMC regulatory / Veeva Document Management / Post-Marketing / Remediation/English

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

? Experience with commercialized products, emphasizing post-approval regulatory maintenance, system

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