Company description:
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and over 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
Job description:
PPD has a new opportunity for a Manager, to join our Regulatory Affairs department. This is a fantastic new opportunity to advance your regulatory career in an exciting and fast paced environment. This position is based in Italy.
The purpose of this role is to provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. In addition, provide country level support within the regulatory intelligence network and the strategic regulatory authority relationship network.
Main responsibilities of the role include:
-Prepares and review regulatory submissions
-Reviews and provide technical advice to prepare regulatory submissions
-Provides regulatory strategy advice to internal and external clients
-Provides project-specific strategy, technical expertise and co-ordination oversight for key client’s projects
-Ensures quality performance for key/managed projects
-Manages project budgeting/ forecasting
-Assists in identifying and recognizing out of scope activities in a contract in a timely manner
-Assists business development in pricing and securing new business by making presentations to clients, developing proposal texts and budgets
-Provides guidance, training, coaching and mentorship to personnel
-Participates as required in project Launch Meetings, Review Meetings and Project Team meetings
Required profile:
Education and Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience
Extensive experience of regulatory agency interactions in Italy covering clinical trials
Experience in a client facing role, and leading global regulatory projects
Knowledge, Skills and Abilities:
· English and Italian language
• Good interpersonal skills
• Familiar with computers and their applications, e.g. Word, Excel, PowerPoint
• Effective oral and written communication skills
• Good organizational and planning skills
• Good negotiation skills
• Ability to work on own initiative
• Proven ability to work effectively in a team environment
• Ability to motivate and integrate teams and teach/mentor team members
• Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management
• Expert knowledge of ICH and other global regulatory guidelines
• In-depth knowledge in clinical trials
• Ability to discipline and reward employees and perform timely, effective performance evaluations
• Good judgement and decision-making skills
• Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc)
• Knowledge of budgeting and forecasting
What we offer:
If you are passionate about your work, and want to apply and develop your skills, PPD provides rewarding career opportunities in a variety of fields. Individuals who are motivated and enthusiastic team players thrive at PPD and ultimately help our clients accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs.
Sede di lavoro:
Milano