Regulatory Specialist – Commercial​/Post-Marketing & Remediation

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 position focuses on post-approval maintenance, change controls, regulatory deviations, and lifecycle management of marketed products. The successful candidate will work across complex regulatory environments while ensuring compliance and operational excellence.

• Minimum Bachelor degree within a relevant field
• 3-4 years of CMC regulatory and technical regulatory experience
• Fluent in verbal and written English (C1)
• 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.