Regulatory Specialist - Commercial/Post-Marketing & Remediation

ITech Consult AG; Basel; On-site; CHF 100,000 - 140,000; Full time

Job summary

Roche in Basel is seeking a Regulatory Specialist (CMC) on a contract basis to manage Health Authority interactions related to CMC information for IND, IMPD and NDA/BLA/MAA filings, and to drive pre-submission meetings with global authorities and partners. You will engage with affiliates and stakeholders across the product lifecycle in a dynamic, cross-functional environment.

The ideal candidate holds a Bachelor's degree in a relevant field, C1 English fluency, and 3+ years of regulatory affairs

Responsibilities

• Handle Health Authority interactions pertaining to CMC information for IND, IMPD and NDA/BLA/MAA filings.
• Lead informational and pre-submission meetings with global Health Authorities and partners.

Job description

Regulatory Specialist - Commercial / Post-Marketing & Remediation

CMC / IMPs / Clinical Trial Applications (CTAs) / Change Control / Deviation Management /Change controls / CMC regulatory / Veeva Document Management / Post-Marketing / Remediation/English

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 Roche. At Roche, 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.

The Perfect Candidate:

The perfect candidate holds a Bachelor's degree in a relevant field, C1 English fluency, and 3-