Head Regulatory Affairs Italy -Start-Up Big Pharma OTC Division RM Roma

As Italian Head of RA Person, he assumes the responsibility for pharmaceutical activities in the framework of the Italian regulations & guidelines in relation to our Client Establishment License in compliance with Good Manufacturing and Good Distribution Practices (GMP/GDP). As Head Regulatory Affairs, the Head RA is responsible for providing strategic and operational leadership for the planning, management, support and execution of Italian regulatory activities for new and marketed products across all therapeutic areas. Close relationship with the Global Regulatory Group in our Client HQ The incumbent is also responsible for ensuring that regulatory strategies are executed in compliance with current, applicable Italian regulations and standards. The Head RA leads the regulatory team & works cross-functionally with internal departments such as, but not limited to, QA, R&D, CMC, Marketing & Sales, as well as external resources as needed on Regulatory and QA-related issues. The position reports to Head of Regulatory Global and dotted line on the the Country Manager, Italy and is based in Roma. Main duties/responsibilities: Regulatoryaspects: The Head RA participates to the development and implementation of worldwide regulatory strategies for products under development and lifecycle maintenance for products on the market including all local representative activities (PV, Complaint management, Advertising and Promotional control, Medical information)Ensures efficient coordination with Corporate Regulatory Affairs and other internal key stakeholders such as CMC/Quality, non-clinical & clinical teams to meet business objectivesDevelops and maintains outstanding relationship with national competent Health AuthoritiesSelects and proposes regulatory strategiesHas Experience in EU registrations through national procedures, MRP/DCP, CP,In charge of the regulatory post-marketing and regulatory complianceProvides support for price and reimbursement dossier for medicinal productsProvides guidance, interpretation and opinions on complex regulatory matters outlining the different outcomes for our ClientProvides technical leadership, training and vision by interpreting regulatory affairs initiativesManages local service providers Project management: Project leader in projects involving various internal functions and coordination of external consultantsDefinition and handling timelinesPreparation of GANT for the presentation to the customerManagement of the budget linked to the different projects Business aspects: Support to business units and part of the executive committeeEstimation of the time necessary to perform a specific project in order to reach the time-to-market. Licensing aspects: Collaboration during due diligence for the acquisition of single products or company assetsEvaluation of the registration dossiers and the identification of possible weaknesses in terms of business. GMP field: Preparation and / or approval of the SOP and the documentation about the activities of the teamSupport during inspections and implementation of corrective actions Head Regulatory Affairs Italy – Whole Business Unit Management Start-Up Big Pharma OTC Division Bachelor’s degree in a scientific discipline or Pharm.D and a minimum of 10 years of successful experience in Regulatory Science and Quality Assurance (or Quality Control) experience in a pharmaceutical industry. The position also requires a minimum of 5 years of leadership experience as a Head Regulatory Affairs role. Special knowledge or skills needed:Very good understanding and several years of experience in pharmaceutical industry in Regulatory, Supply Chain, Quality Control and/or Quality Assurance. Prior experience leading a Regulatory Affairs function, including the associated staff for a mid-sized organization.Direct contact and negotiation experience with Italian competent authorities.Demonstrated track record of success building relationships with, and influencing, national health authorities, particularly in situations requiring direct interaction/negotiation.Demonstrated record of success in gaining regulatory approvals in Italy.Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.Ability to influence without direct authority.Good negotiating and interpersonal skills, as well as an excellent verbal and written communication in English and in Italian.Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.Ability to travel mainly in France and internationally (mainly in Japan), as neededWork extended hours as required on time sensitive projects to achieve deadlines. Our Client, an international Big Pharma companyOttima opportunit di carriera.


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