Regulatory Affairs Relocation Lead - Basel

(FCRS = BR012) SANDOZ DO BRASIL IND FARMACEUTICA LTDA; Rotkreuz; On-site; CHF 110,000 - 170,000; Full time

Job summary

Sandoz is seeking a Regulatory Affairs Specialist to lead the Basel relocation address-change workstream from Rotkreuz to Basel, overseeing end-to-end regulatory updates, artwork changes and Swissmedic submissions where applicable.

The role collaborates with RA, QA, Supply and artwork teams to ensure timely, compliant implementation and handover of records into permanent RA after the relocation.

Qualifications

• Adhere to Sandoz values and behaviors policies
• Adhere to Sandoz's anti-bribery, confidentiality, and ethical standards and policies.
• Adhere to relevant GxP and pharmacovigilance requirements as established in the processes and tools.

Responsibilities

• Own the portfolio impact assessment and maintain a complete, reconciled inventory of all affected Sandoz Swiss-market artworks, packaging components and related product information requiring the address change from Rotkreuz to Basel.
• Lead the address-change workstream, defining the regulatory implementation plan, priorities, responsibilities and milestones in alignment with local RA and the relocation program.
• Oversee updates and regulatory review of packaging texts and related product information, including affected language versions, ensuring consistency of the Basel address and completion of required approvals.
• Assess applicable Swissmedic submission requirements, agree on the approach with local RA, and manage preparation, review and submission of address-change applications or notifications where applicable; lead submission follow-up and responses to authority questions within delegated authority.
• Lead artwork workflows from change initiation through review and approval of revised artwork, aligning artwork teams, QA, Supply and manufacturing or packaging sites on responsibilities, priorities and delivery dates.
• Manage updates and reconciliation of affected records in regulatory databases, artwork management systems and project trackers, ensuring accurate address data, submission status, approvals and implementation dates.
• Align artwork availability and packaging implementation with relocation milestones and supply plans; manage dependencies, develop mitigation actions and elevate decisions or risks requiring project leadership or local RA approval.
• Own the consolidated project tracker and provide decision-oriented progress reports covering milestones, artwork updates, system changes, submissions, outstanding actions and implementation risks.
• Ensure complete, inspection-ready archiving of project-related regulatory documentation, approved artworks, authority correspondence and implementation evidence in designated repositories.
• Lead communication with internal and external stakeholders, resolve address-change queries and secure alignment on decisions, responsibilities and deliverables.
• Lead project closure, reconcile the affected portfolio, confirm completion against agreed criteria and deliver a documented handover of records and outstanding actions to the permanent RA team.

Job description

Sandoz is seeking a Regulatory Affairs Specialist to lead the Basel relocation address-change workstream from Rotkreuz to Basel, overseeing end-to-end regulatory updates, artwork changes and Swissmedic submissions where applicable.

The role collaborates with RA, QA, Supply and artwork teams to ensure timely, compliant implementation and handover of records into permanent RA after the relocation.