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Open nowPosted 2 days ago

Regulatory Affairs Specialist CMC and Commercial / Post-Marketing & Remediation

Coopers Group AG

Where
Basel Stadt, Switzerland
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Your applicationOpen nowRegulatory Affairs Specialist CMC and Commercial / Post-Marketing & RemediationCoopers Group AG · Basel Stadt, Switzerland

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  5. 35.6%30 days
  6. 58.1%60 days
This job: posted 2 days ago

The posting

  • Life Sciences - Regulatory Affairs
  • Basel-Stadt
  • Contracting
  • Teilzeit, 100%
  • Regulatory Affairs, CMC, IMPD

Location: Basel

Duration: 12 months

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:

CMC 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\\

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.

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