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

C115 (FCRS = CH115) Sandoz Pharmaceuticals AG; Rotkreuz; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Sandoz Pharmaceuticals AG in Rotkreuz Basel relocation project seeks a Regulatory Affairs Manager to lead the address-change workstream for the Swiss market, overseeing regulatory updates across artworks, packaging, and system records.

You will coordinate Swissmedic submissions, align with RA, QA, Supply, and artwork teams, and ensure timely, traceable delivery from assessment to handover under delegated authority.

Qualifikationen

• Bachelor’s degree in biomedical, life or pharmaceutical sciences with substantial regulatory experience.
• 3+ years of regulatory affairs experience, including lifecycle changes and cross-functional projects.
• Fluent German and English; French and Italian desirable.
• Experience managing Swissmedic submissions and packaging/artwork workflows.
• Ability to lead cross-functional regulatory projects with governance and documentation control.

Aufgaben

• Lead the regulatory address-change workstream for the Rotkreuz to Basel relocation.
• Coordinate submissions, approvals and follow-up with Swiss authorities where applicable.
• Manage artwork revisions, packaging texts and language versions.
• Maintain regulatory databases and project trackers with accurate data.
• Provide guidance to internal stakeholders and ensure timely delivery against milestones.

Kenntnisse

Regulatory affairs

Cross-functional collaboration

Project leadership

Swissmedic submissions

Documentation control

Ausbildung

Bachelor’s degree in biomedical/life/pharmaceutical sciences

Postgraduate qualification desirable

Tools

SAP

Regulatory databases

Artwork management systems

Jobbeschreibung

Job Description Summary See Job Description.

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

Your responsibilities include, but are not limited to:

Your 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 local RA approval. Own 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 assessment of applicable Swissmedic requirements with local RA and incorporate confirmed requirements, sequencing and approval dependencies into the implementation plan. Ensure address updates in related regulatory documents and records are assigned, coordinated and completed by the responsible functions where affected by the move. Manage workstream scope and priorities; assess impact of additional requests and agree changes to deliverables, resources or timelines with the line manager and project leadership.

What you’ll bring to the role:

Essential and Desirable Requirements: Bachelor’s degree in biomedical, life or pharmaceutical sciences, or an equivalent qualification with substantial relevant regulatory experience; a postgraduate qualification is desirable. 3+ years of relevant pharmaceutical Regulatory Affairs experience, including independent management of lifecycle changes and cross-functional implementation projects. Fluent German and English, both written and spoken; French and Italian are desirable. Hands‑on experience managing Swissmedic submissions and lifecycle changes, with sound knowledge of Swiss regulatory requirements and packaging/artwork approval workflows. Demonstrated ability to lead cross-functional regulatory projects in a regulated environment, managing controlled documentation, approval dependencies and implementation across multiple products. Strong project leadership, planning and prioritization skills, with the ability to independently manage a high-volume workstream, competing deadlines and implementation risks. Sound regulatory judgement and analytical problem‑solving, combined with excellent attention to detail, data integrity and accountable follow‑through. Confident stakeholder management, influencing and decision‑oriented communication, with the ability to lead without direct reporting authority and escalating issues constructively. Proficiency in MS Office, particularly Excel, and confidence using regulatory databases and artwork/document management systems; SAP experience is desirable.

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low‑cost, high‑quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster.

Commitment to Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and accommodation

Sandoz is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e‑mail to [e-mail] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in "off‑patent" high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more!