The story of PRA Health Sciences would naturally talk about how we’ve become one of the world’s largest CROs. It would talk about our innovation and growth and would speak to our operational efficiencies and transparency. It would highlight our expertise and customization. And it would touch on the incredible differences we’ve made, over our more than 30 years, in helping to bring to market everything from niche treatments and therapies to blockbuster drugs.
More than anything else, our story would be about people. Not only our over 15,000 employees operating in more than 85 countries, though they’d certainly be a big part of it, but also the people that inspire them. The heroes of any PRA Health Sciences story are the clients we serve and the people whose lives we help improve, all over the world. And our story has only just begun.
We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.Who are we?We Are PRA.We are17,000+ employees strong, operating in more than90+countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact isrealand we see it every single day.We help get life-saving drugsinto the handsofthose who need them most. Who are you?You are a leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for labeling. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
What You Will Be DoingAs an Associate Regulatory Project & Submission Manager, you will effectively work with global/regional cross functional teams to plan, prepare and deliver compliant regulatory projects and submissions. The aRPSM introduces flexibility within and across therapeutic areas and marketed products to provide broad regulatory project support to ensure all submission and business deliverables are met in a timely manner. With support from the Regulatory Project & Submission Management Lead (RPSM) or Line Manager and in collaboration with key members from regulatory affairs, the aRPSM will compile and execute submission strategy plans for new INDs and global marketing authorizations as well as submission strategies for the maintenance of existing drug licenses.The aRPSM promotes a global e-working environment via strong partnerships with Global Regulatory Operations (GRO) personnel and drives efficient, standardized best practices for regulatory submission documentation necessary for applications via the end-end submission model to approval, through product launch and beyond.The aRPSM is assigned to projects with regional submission focus or those of less complexity, with support and guidance from the RPSM Lead or line manager,With support from the RPSM Leads or Line Manager, the aRPSM continually monitors, interprets and validates current and evolving external agency submission standards/policies and assesses the potential impact to submission processes to ensure compliance and efficiency in the delivery of submissions.With support from the RPSM Lead or Line Manager, the aRPSM contributes to solutions to regulatory submission issues by ensuring potential risks are identified and mitigation plans are put in place. This position also contributes to continual process improvement and change management procedures.The above will be carried out according to regulatory guidelines as well as PRA relevant SOPs. This position will also ensure that PRA is aware and responsive to external guidelines, regulations, changes in the marketplace and other information relating to global regulatory submission management.The aRPSM will act in a manner befitting PRA core values.Supervised (as appropriate) management of the cross-functional global submission teams in the delivery of compliant submission components according to agreed timelines and processes. This includes planning and co/hosting ‘kick-off’ meetings and preparing appropriate materials to facilitate team discussion, timeline mapping and submission strategy.Creation of submission risk, escalation and communication plans (as appropriate)Conduct regular lessons learnt sessions to encourage process improvement and efficiencies within and across submission project teams.With input from the RPSM Lead or line manager, maintenance of a submission forecast for functional/resource planning, in alignment with the Global Regulatory Plan.Familiarity with MS-Project in order to create and maintain detailed submission schedules Champion embedded processes and best practices within the global and local cross functional areas in the creation of global submission ready documentsFacilitates agreement on realistic dates for document handover in collaboration with the publishing group.Facilitates the development of a global submission document plan (TOC) which specifies source submission content and tracks document creation through to approval and publishing.Proactively escalates any timeline concerns, risks and issues that may delay/impact the project and engages appropriate representatives to manage outcomes.Acquires an understating of the internal and external interdependencies among activities on a submission that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are achieved on time and to the highest quality.Become a global submissions expert, and ensure the project team has sufficient awareness and knowledge of e-submission principles and lifecycle management; understands, represents and communicates regional differences as appropriate within the context of global submission preparation.The aRPSM will be assigned during pre-submission planning stages.Generally, the aRPSM has sole responsibility for smaller and less complex projects/workload, but may leverage the expertise of the RPSM or Line Manager as requiredEach compound/product will be assigned a dedicated RPSM as appropriate. The aRPSM may engage support from another RPSM with large global complex projects during peak submission activity.General:The aRPSM partners with the RPSM Leads or Line Manager to effectively forecast and manage project specific resources utilizing flexible resourcing, and employing global load sharing as standard business practice.The aRPSM shadows RPSM or Line Manager with the interpretation of industry or health authority guidance related to submissions and communicate to project teams as appropriate.Promotes an e-working environment and culture at PRA.
What do you need to have?Bachelor’s degree (or significant proven experience in a pharmaceutical environment)Experience working within a Regulatory or Project Management environment.Atleast 5 yrs of relevant experienceProven experience in developing and implementing novel technological solutions and processes.Understanding of document management systems and concepts experience of multitasking in a deadline controlled and preferably highly regulated environmentAwareness of regulatory procedures and a wider understanding of patient safety and commercial registration status.Working experience of CTAs, INDs, CTD dossiers for MAAs. Including post marketing submissions such as variations, renewals, labelling etc.Qualified project management experienceExperience of introducing new systems and procedures based on interpretation and application of regulatory agency guidance documents and mandated legislation.Skills:Analytical and Problem Solving Skills - excellent ability to identify critical issues and understand complex issues and propose creative and achievable solutions. Determines the causes of and potential solutions to the problemCommunication Skills - ability to express oneself clearly and concisely to stakeholders over the phone or with others within a team; documents issues and/or concerns concisely and comprehensivelyPolitically astute – and a confident and self-motivatingInterpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievementKnowledge Sharing - identifying & filling knowledge gaps and sharing intelligence to improve team effectiveness.Shares information with staff as confidentiality allowsChange Management – ability to identify, advocate and implement change positively for the organization. Demonstrates flexibility and the ability to accommodate change.Teamwork - the ability to work well in a highly cross-functional matrix environmentStrategic Approach - identifies, creates and implements process improvements for document management and regulatory submission publishing that satisfy business objects of PRA globallyPRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.Job SummaryID: 2019-57360