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

• 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.