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Open nowPosted 3 days ago

Regulatory Specialist

ELAN Personal AG

Where
Basel, BS, Switzerland
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Your applicationOpen nowRegulatory SpecialistELAN Personal AG · Basel, BS, Switzerland

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This job: posted 3 days ago

The posting

Regulatory Specialist ---------------------

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Regulatory Specialist =========================

Background:

At Roche, they believe in empowering you to thrive and do your best work. By bringing together their 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 two professional Regulatory Affairs Specialists to join the 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.

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

Position 1: Regulatory Specialist -- Clinical / Early-Stage Development (CMC Focus)

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

Position 2: Regulatory Specialist -- Commercial / Post-Marketing \& Remediation

  • Experience with commercialized products, emphasizing post-approval regulatory maintenance, system integration, and extensive legacy data clean-up
  • Commercial product support, post-marketing submissions, change controls, and managing regulatory deviations
  • Working knowledge of legacy/old product clean-up
  • Proactive problem-solving and "thinking outside the box" to streamline records and ensure compliance
  • Strong proficiency in the Veeva RIM (Regulatory Information Management) environment

Nice to Haves:

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

What you will be offered:

  • An opportunity to work in one of the world's most important pharmaceutical companies
  • Modern campus with plenty of green spaces and meeting areas
  • Central location in Basel
  • Varied job profile
  • Further training opportunities through temptraining
  • Working in a dynamic and motivated team

If you are interested please send your application documents addressed to Ms Diana Afonso.

Basel-Stadt Pharma Regulatory Aargau Solothurn Clinical Commercial Management CMC Veeva PTR CTA

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