Regulatory Affairs Manager (d/f/m) - Temporary 24-month Contract

(FCRS = BR012) SANDOZ DO BRASIL IND FARMACEUTICA LTDA; Rotkreuz; Presencial; CHF 120.000 - 170.000; Jornada completa

Descripción de la vacante

Sandoz is relocating its Basel site and this temporary Manager position leads the Regulatory Affairs address-change workstream from Rotkreuz to Basel, owning the end-to-end update across Swiss-market artworks and any Swissmedic submissions where applicable.

You will coordinate with RA, QA, Supply and artwork teams to ensure timely, compliant delivery, manage risks, and deliver a documented handover to the permanent RA team at close of the project.

Descripción del empleo

Workplace

Rotkreuz, Switzerland until 31 December 2027; Basel, Switzerland as of 01 January 2028. This position is offered on a temporary 24-month contract.

Overview

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Position Summary

This temporary Manager position leads the Regulatory Affairs workstream for the Sandoz office relocation from Rotkreuz to Basel. The role owns the end-to-end address update across all affected Sandoz artworks for the Swiss market and manages related regulatory system updates and Swissmedic submissions, where applicable, in alignment with local RA governance and delegated approval authority.

The role is accountable for timely, accurate and traceable delivery of the regulatory address-change workstream, from impact assessment and implementation planning through artwork approval, submission follow-up, system reconciliation and documented handover. The Manager leads cross-functional alignment with RA, QA, Supply, artwork teams and other project stakeholders, manages priorities and dependencies, and drives risk mitigation to support supply continuity.

Key Responsibilities

Team and culture

Adheres to the Sandoz V&B's.

Compliance

Guarantees adherence to the relevant (local) procedures, and record management.

Supports RA during internal and external audits and health authority inspections at country level.

Basel relocation: artwork, systems and regulatory implementation

• 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 overall relocation program, including:
  • Drive address-change requests and delivery, establishing product-level ownership, deadlines and dependencies and resolving implementation issues within delegated authority.
  • 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.

General Sandoz requirements;

• 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.

Project-specific coordination:

• Represent the regulatory address-change workstream in cross-functional Basel relocation meetings, lead relevant working sessions and drive agreed actions to closure.
• Provide regulatory guidance to local stakeholders and global teams, translating the agreed address-change approach into actionable implementation requirements.
• Lead the assessment of applicable Swissmedic requirements w