Head of Medical and Regulatory Affairs for Italy
2 ore fa
We are seeking an experienced Head of Medical and Regulatory Affairs to lead our medical and regulatory affairs activities in Italy. As a key member of our leadership team, you will be responsible for ensuring that all medical and scientific support activities are conducted with the highest level of quality and compliance.
Key Responsibilities- Develop and implement strategies to ensure medical and scientific support of recognized quality to both local and corporate clinical and clinical-marketing projects.
- Manage activities to launch and implement clinical projects, ensuring compliance with regulations and achieving goals within planned time and costs.
- Develop and negotiate, together with GM, the approval and reimbursement process of new products and/or indications, in line with HQ guidelines.
- Ensure the highest level of medical and scientific knowledge about the Company's products and potential evolution guidelines, interacting constantly with Corporate.
- Represent the company's referee for pharmaceutical and health legislation at national and international level.
- Ensure the company's presence in the medical and scientific field related to the products of the Company, through monitoring specialist MDs/KOLs, the Research Centers of Excellence and the most validated institutes in the treated medical disciplines.
- Supervise, in close collaboration with Corporate and the Director of Operations, by providing medical and scientific expertise, the identification and definition of the most effective marketing and clinical projects aimed to the improvement and development of products and/or indications for their market success.
- Control, in collaboration with Regulatory Affairs, the management of local/corporate medical and clinical projects (LMA, GMA, DD), ensuring full compliance with QSE (Quality, Safety, Efficiency) regulatory requirements, Good Clinical Practice (GCP) and ethical guidelines.
- Supervise and guarantee, as Head of the Scientific Service (RSS) in the company, the quality of the information and business documentation, in compliance with the quality standards and the current legislation.
- Minimum: Science/Medical related qualifications at a Post Graduate level, Fluency in English, Hospital product experience, Proven track record of working with Pharmaceutical Specialised products, preferably within the Cluster/Country Market.
- Significant experience in, and knowledge of, product/products specialty markets with complex science and reimbursement.
- Demonstrated experience in successfully leading and managing a high performing team.
The estimated salary for this role is €120,000 - €150,000 per year, depending on experience.
BenefitsThis role offers a competitive salary package, including a bonus structure and comprehensive benefits package.
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