Regulatory Specialist-Clinical​/Early-Stage Development

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.

• 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.

This role is focused on early clinical stage development, specifically supporting Investigational Medicinal Products (IMPs) and Investigational Medicinal Product Dossiers (IMPDs).

• 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 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**