Senior Regulatory Affairs Specialist

at  Ecolab

The Regulatory Affairs Sr Specialist will be supporting the implementation, execution and management of the local regulatory activities in Italy ensuring regulatory compliance with local regulatory requirements and corporate policies.
The Regulatory Affairs Specialist supports interactions with the national Regulatory Authorities, i.e. AIFA and Ministry of Health.
The position could be based in Vimercate Office (MB) or Settimo di Pescantina Plant (Verona) - hybrid model work.

EXPERIENCE IN THE PHARMA INDUSTRY IN REGULATORY AFFAIRS, INCLUDING EXPERIENCE IN A SIMILAR POSITION. PREVIOUS EXPERIENCE IN BIOTECH INDUSTRY WILL BE A PLUS

• Good knowledge of applicable local and global pharmaceutical regulations and related ethical code of practice required for GXP compliance
• Ability to pragmatically interpret GxP and Code of Practice regulations, laws and guidelines with ability to share
• CMC experience
• Experience with MRP and DCP and global projects innovation and life cycle
• Experience in review of promotional and non-promotional materials and activities.
• Strong written and verbal communication and organizational skills
• Ability to work independently and collaborate effectively with cross-functional colleagues at all levels of the organization.
• Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
• Ability to multi-task and prioritize work.
• Fluency in English (speaking, reading, and writing)
• Knowledge in QMS activities and Electronic Quality Systems.
• Proficiency in Microsoft applications (Excel, Word, PowerPoint)

EDUCATION

• Bachelor’s degree or equivalent, preferably in life sciences (pharmacy, biology, etc.).
• Master in Regulatory Affairs will be a plus.

This position contains tasks related to regulatory area.
Tasks may change over time across and within the respective areas depending on business needs.

Support the Regulatory Affairs team in the planning, coordination and management of regulatory activities:

• Regulatory submissions to national regulatory authorities as needed
• Manage labeling activities (SmPC, package leaflet and labeling) as per local requirements and internal processes
• Ensure approved Annexes and packaging changes Artworks are implemented timely, for products under its own responsibility
• Regulatory revision of educational materials, if required.
• Regulatory review and submission to HA of promotional and non-promotional materials in accordance with the Pharmaceutical Law 219/2006, AIFA guidelines, internal SOPs and Farmindustria Code.
• Maintenance of the regulatory quality management system (QMS), follow-up with Corrective Action Preventative Actions (CAPAs) and changes
• Drafting and updating SOPs under regulatory responsibility.
• Provide support in the training on SmPC/Educational Materials, if required.
• Maintain compliance of the managed activities and assure proper archiving of all relevant documents related to those activities.
• Preparation and submission of variations
• Update of national databases
• Support the regulatory team during audit and inspection.
• Monitor regulatory/pharmaceutical regulations (Regulatory intelligence) for the relevant therapeutic areas and share information internally.
• Can be assigned as Lead to specific products and projects.
• Communicate with Third Parties on the registration of Company products outside Europe
• Support to Cross-Functional Projects
• Deal with Pharmacovigilance tasks
• Customer service support
• Support the preparation of documentation for tenders

Qualifications