MEDICAL AND REGULATORY AFFAIRS DIRECTOR

Scelte Strategiche is seeking a Medical & Regulatory Affairs Director for a pharmaceutical multinational company (job location.
Milan).
Purpose of the position To ensure, within Corporate and company strategic and management policies, medical and scientific support of recognized quality to both local and Corporate clinical and clinical – marketing projects aimed to the development and improvement of Products and/or directions, working actively with Marketing for the definition of effective product plans.
Manage activities to launch and implement clinical projects, ensuring compliance with regulations and ensuring the achievement of goals and compliance with planned time/ costs.
To develop and negotiate, together with GM, the approval and reimbursement process of new products and / or indications, in line with HQ guidelines.
To be a member of the Company Donation Committee and guarantor of its operations.
To be responsible for the compliance of the Scientific Service.
To monitor Regulatory Affairs by holding the relationship with the Ministry of Health / AIFA, Regions and public health institutes at national level.
Main responsibilities & tasks of the role.
Strategy definition 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   Strategy execution & monitoring 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.
KOLs management Build an effective network with the main external interlocutors (KOLs, Scientific societies, communication agencies) Represent the Company in congresses Regularly visit customers   Organization and People development Propose and lead optimal marketing/sales organization Ensure recruitment, development and retention of staff Energize the team behind common objectives and goals Ensure cross functional collaboration through brand teams Foster and develop the action principles within the Business Unit   Local management team member Contribute to cross functional collaboration of local leadership team Participate actively to the life of the affiliate, endorse decisions taken on all subjects   Ethics & Compliance Ensure the respect of Company procedures and working standards and SOPs, and particularly the implementation of the Ethical Code of Conduct within the Business Unit.
Skills and Experience.
Science/Medical related qualifications at a Post Graduate level 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 Experience working within an environment of strict compliance to all appropriate regulatory guidelines to successfully design and execute tactics, programs and tools that achieve business objectives Demonstrated experience in successfully leading and managing a high performing team Ideally 10 years pharmaceutical medical experience, of which, 5 years as a people manager Extensive product/products specialty markets knowledge and experience in a Pharmaceutical industry environment Successful experience in the management of products life cycle.
launch, development, maintenance Extensive product/products specialty markets experience and knowledge Established relationships with KOLs, patient groups, etc.
P&L management     Other competencies   Strong analytical and numerical skills and an ability to manage complex situations and make expedient decisions, execute plans and achieve outcomes Excellent organisation, planning, implementation, budgetary and project management abilities Fluency in English  International experience is a plus     La ricerca è rivolta ad entrambi i sessi (L.).
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