Job Description
Candidate Information Pack - Please read before applyingPLEASE NOTE: Closing Date is Friday 14th June at 12pm, BST.This is a hybrid role for Northern Ireland employees (2-3 days per week in the office) and remote for UK/Ireland.Background:At Diaceutics we believe that every patient should have access to the right treatment at the right time. We provide the world’s leading pharmaceutical companies with an end-to-end solution for the launch of precision medicine diagnostics enabled by DXRX – The Diagnostic Network.DXRX is the world’s first diagnostic commercialization platform for precision medicine, integrating multiple pipelines of real-world diagnostic testing data from a global network of laboratories.Position Summary:As our organisation continues to grow we are looking for a Head of Compliance / Regulatory Affairs who will provide worldwide, strategic leadership in and comprehensive understanding of the government regulatory requirements for product development utilizing regulatory knowledge and expertise to ensure regulatory compliance.Duties and Responsibilities: Responsible for regulatory oversight and intelligence. Develop and implement strategies for the timely preparation and execution of regulatory documents to regulatory authorities for contracted programs. Provide expert analysis and evaluation of regulatory information. Informs the teams (internal and external stakeholders, as needed) of the regulatory status of products / programs and significant regulatory issues. Provide analysis of regulatory guidance documents, regulations or directives that influence Precision’s operations and impacted programs. Advise other departments as well as external stakeholders regarding their applicability and impact. Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures. Develop global regulatory strategy(s) for contracted clinical programs to ensure successful initiation, execution and submission for global registration. Lead and /or facilitate team preparation for regulatory agencies/Health Authority meetings. Lead and /or facilitate communications with regulatory agencies. Preparation of briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs/BLAs, and Annual reports. Provide oversight to study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications. Lead, oversee and coordinate critical reviews and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports). Provide guidance and leadership to the members of the Team. Develop, define and lead internal growth and resourcing strategy for Regulatory Affairs within the organization and direct and oversee all regulatory staff. Oversee the development and management of the regulatory infrastructure. Develop and manage a global budget and resourcing supporting the Team. Lead Regulatory Affairs business development activities. Contribute to development of regulatory consulting business to support client development and growth, to achieve an initial annual sales target for regulatory-specific work (outside of clinical trial support). Key Attributes Required: People Skills: Line manage or effectively manage the performance of other people's work through projects, including effective delegation of tasks and responsibilities. Customer Service / External Impact: Accountable for effective communication with external stakeholders and suppliers, often dealing with sensitive information and a considerable amount of confidential data. Decision-Making: Proven ability to make complex decisions based on agreed frameworks and processes. Initiative and Independence: Develop and implement concepts and ideas that may impact the future performance of Diaceutics. Knowledge and Specialist Skills:Education: Bachelor’s degree in a related discipline.Experience: 10+ years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience. Expert knowledge of all aspects of the drug development process inclusive of regulatory milestones. Significant experience in all aspects of meeting with Regulatory/Health Authorities supporting drug development. Ability to apply knowledge of FDA, EMA Global Health Authority requirements and ICH guidelines both strategically and operationally and provide direction to resolve complex regulatory issues. Expertise in preparing complex regulatory documents and other major regulatory submissions. Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills. Strong interpersonal and client-facing skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of business development and pharmaceutical collaborating are necessary. Proven ability to communicate with management, external thought-leaders and operational staff. Ability to guide, train and supervise personnel; oversees the work of direct reports to ensure ontime, on target and within budget results. Flexible attitude with respect to work assignments, and new learning opportunities. Prior experience in business development activities. Availability for domestic and international travel including overnight stays. Computer and software Knowledge and Skills – Proficient in Microsoft Office Suite, skilled user Excel and PowerPoint. Desirable: Advanced degree. Experience growing and managing a global regulatory function – CRO and Pharma experience preferred. Experience in Healthcare, medical device or in vitro diagnostics and or consulting is desired. Prior work experience in haematology/oncology. Life at Diaceutics:We are a multi-cultural, diverse team spanning 14 countries around the world. One thing we all have in common is that we are dedicated people who are passionate about patient outcomes. All of our employees work remotely or in a hybrid model and we collaborate together as a global community.At Diaceutics, we live by our values, The Diaceutics EFFECT. Diaceutics community is Empowered to explore new ideas and paths, and to develop new solutions for our pharma clients and lab partners. By applying Foresight, innovative and entrepreneurial skills we can lead at the forefront of Precision Medicine. Fun is what makes life working at Diaceutics so special as it is the fuel of what we do, both internally and externally. Special care for Empathy allows us to create an open environment for working together, being listened to and understood, even when working remotely. Communication has a special place at Diaceutics, being key across all our interactions, where we assume positive intent which leads to widespread Trust across our community.We hire smart, fun people who care about our mission and about each other. Some interesting points about us: Competitive salary (and attractive bonus scheme dependent on role). Training and development opportunities. Remote / Virtual Working. Flexible Working incl. Flex Day Programme. Share Incentive Plan. Increase of Annual Leave with tenure. Pension. Healthcare (including Vision and Dental) and Additional Benefits e.g. Employee Assistance Programme. Life Insurance. Group Income Protection. Enhanced Maternity and Sick Pay Provisions. Robust Performance Management Framework and Individual Development Plan. Generous Staff Referral Scheme. Dedication to positive working culture with regular health and wellbeing activities and annual company get together. We are an equal opportunities employer and we welcome applications from all suitably qualified persons.Please see link below to our Candidate Privacy Statement:https://www.diaceutics.com/privacy-statement #J-18808-Ljbffr