Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist will support Sandoz’s pharmaceutical portfolio by monitoring regulatory developments, preparing and maintaining submissions, and ensuring compliance throughout the product life‑cycle. This role works closely with internal functions and external health authorities to safeguard market access and product quality.

Key responsibilities

• Monitor local and international regulatory changes and communicate impacts to relevant functions.
• Develop and execute regulatory strategies for new product registrations and lifecycle management.
• Prepare, compile, and submit technical dossiers, including CMC, bioequivalence, PSURs and RMPs.
• Manage regulatory maintenance activities such as MA renewals, label updates, and supply‑limiting changes.
• Liaise with health authorities, respond to Letters of Authority Questions, and track approval timelines.
• Coordinate outsourced regulatory agents, control expenses, and approve related invoices.
• Oversee product discontinuations and contribute to portfolio optimisation.
• Review promotional and non‑promotional materials for regulatory compliance.
• Support launch preparations, tender processes, and first‑batch control in collaboration with cross‑functional teams.

Required profile

• Strong understanding of local and international pharmaceutical regulations.
• Experience preparing regulatory submissions and managing product life‑cycle activities.
• Ability to work effectively with cross‑functional teams and external agencies.
• Excellent analytical and communication skills for interpreting regulatory requirements.
• Proactive attitude toward continuous learning of regulatory trends.

Required skills

• Regulatory intelligence and monitoring.
• Preparation of CMC, bioequivalence, PSUR and RMP dossiers.
• Interaction with health authorities and handling of LoAQ responses.
• Management of outsourced regulatory activities.
• Knowledge of promotional material compliance.