Regulatory Affairs Specialist
The resource, within Corporate Quality Assurance team, will ensure that a company's products are compliance with national and international regulations:
**Main Activities**:
- Monitor the developments of regulatory projects applicable to the products and keep up to date with national and international legislation, guidelines and customer practices
- Budgeting Formulation necessary to cover the regulatory obligations required and to identify the necessary resources and workloads
- Provide answers to customers and dialogue with them about products' normative and regulatory needs
- Training activities on regulatory policies or procedures
- Consult materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met
- Contribute to the development or implementation of business unit strategic and operational plans
- Represent organizations before national or international regulatory agencies on related to the company's products and management of audit activities
- Within the Compliance team, collaborates with colleagues in order to ensure the correct management of the activities necessary to acknowledge the compliance achieved.
**Skills**:
- Enabling for Auditor activity
- Knowledge of current certifications and regulatory standard
- Fluency in English
- Team Work
- Proactivity
- Problem Solving
- Accuracy, planning, organization, excellent interpersonal and communication skills
**Education**:
- Technical or Scientific degree
**About us**:
Bormioli Pharma operates in a very close partnership with the pharmaceutical industry and all the companies that are shaping the future of healthcare.
An acknowledged world leader in the packaging sector, Bormioli Pharma serves the pharmaceutical and biopharmaceutical market with an integrated offer of bottles, closures and accessories, using advanced materials and technologies.
Being part of Bormioli Pharma means working in a stimulating environment, where innovation is at home and where every talent can express itself to the best of its potential thanks to the mix of skills guaranteed by the different professionalism employed.
An environment where passion and commitment shine, and where initiative, proactivity, autonomy and flexibility are promoted.
**Equal Employees Opportunity
In Bormioli Pharma we strongly believe in inclusiveness and diversity as an enrichment factor.
**Personnel search and selection agencies
It is permitted to download and/or copy parts of the content of the advertisements related to open positions for personal and non-commercial use only, in particular it is prohibited to i) modify or alter the content in any way and ii) distribute, modify, transmit, reuse, republish or use the text, image and video for public or commercial purposes without prior written authorization obtained from Bormioli Pharma S. p. a. .
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