Regulatory Specialist

Regulatory Specialist Regulatory Specialist Regulatory Specialist: CMC / IMPs / Clinical Trial Applications (CTAs) / Change Control / Deviation Management /Change controls / CMC regulatory / Veeva Document Management / Post-Marketing / Remediation/ English / Deutsch Background A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us . At , we believe in empowering you to thrive and do your best work. By bringing together our 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 three professional Regulatory Affairs Specialists to join our 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. Please specify the role you present for within the cover page. The Perfect Candidate: The perfect candidate holds a Bachelor's degree in a relevant field, C1 English fluency, and 3-4 years of technical CMC regulatory experience either specifically focused on early clinical trials, IMPs, and Clinical Trial Applications (CTAs) or regulatory experience managing post-approval maintenance, change controls, and regulatory deviations. additionally, they are proficient in utilizing Veeva Document Management systems to assemble and publish compliant regulatory submissions. Tasks 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