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• Regulatory Affairs Consultant – EU Strategy, • UK-based, Hybrid – 3x a week on-site in Surrey, UK., • 10-to-12-month contract – Inside IR35, • PAYE rate up to £33.78 p/h OR Umbrella rate up to £37.86 p/h JOB SUMMARY • Represent a particular region for regulatory sciences (US, EU or EM), • Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST)., • Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals., • Accountable for timely submissions and approvals with commercially attractive labeling in the designated region., • Accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the assigned project(s) within the designated region., • Role can be combined with other Regulatory Role(s) (i.e., Global Regulatory Lead). JOB RESPONSIBILITIES • Accountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects., • Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post-filing activities., • Partners with project teams and other customer groups to ensure required regulatory contributions (line plans, label, CTA, MAA/IRD, variations, license renewals etc.) meet business needs and are provided to the project teams, to agreed time and quality standards., • Ensures regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) mitigated., • Ensures an aligned regional regulatory position is reached and communicated for all key issues for assigned. JOB DESCRIPTION • Engages in appropriate activities in order to influence the regional regulatory environment through OGRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate., • Ensures business compliance and implementation of and adherence to Regulatory standards., • Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region. QUALIFICATIONS / SKILLS • Scientific Degree. A higher degree may be an advantage but is not essential., • Proven experience in managing national and/or regional regulatory process and registration aspects of the drug development process particularly clinical trials experience at least in one country., • Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable., • Equivalent experience, either at a regulatory agency or working on substantive industry -government collaborations, can be considered., • Experience in communicating with FDA or major EU regulatory agency(ies) for US and EU regulatory strategists respectively, as well as participating in/leading such interactions, is preferred., • Knowledge of drug development practice rules, regulations and guidelines - Familiarity with f actors likely to influence the regulatory environment, including new and emerging guidelines., • Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs / MAA/IRDs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations., • Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management. For more information, please reach out to me at

Join the team at Farmfield Hospital in Charlwood, Surrey as a 0.6FTE Consultant Forensic Psychiatrist. You will be providing strategic leadership and expert psychiatric leadership and clinical oversight within forensic mental health services, acting as Responsible Clinician under the Mental Health Act and delivering high-quality, recovery-focused care to individuals involved with the criminal justice system. As a Consultant Forensic Psychiatrist, you will take on RC responsibility for male service users on our medium secure wards. The RC will have the support of a non-consultant grade doctor as well as secretarial support. Where you will be working: Farmfield Hospital is a 64-bed secure unit with both MSU and LSU wards for male patients. The hospital is purpose built and run by the highly experienced Elysium Healthcare group. The hospital is in the beautiful county of Surrey and has excellent transport links to London and Brighton. Gatwick airport is practically next door! Working with an established multi-professional team, you will deliver individualised care and have access to a large and supportive peer group of like-minded professionals. Your responsibilities will include: • Ensure the adequate working of the Care Programme Approach (CPA) for patients., • Work constructively with other multi-disciplinary professionals to ensure good patient care and throughput., • If needed escalate to the Medical Director or Regional Directors any concerns, in relation to the medical staff, within the region., • Provide clinical leadership to clinical teams including through effective teambuilding and facilitation., • Contribute to the training, education and development of staff of all disciplines, in particular medical staff., • Professionally supervise and appraise medical staff as required., • Ensure the medical and clinical voice is represented in hospital clinical governance meetings., • Ensure effective and efficient delivery of quality medical services., • Guide safe and appropriate implementation of Mental Health Act and Mental Capacity Act in region., • Liaison with external agencies who are stakeholders in patient care., • MBBS or equivalent medical qualification, • Full GMC registration with licence to practice, • MRCPsych or MRCPsych equivalent approved by the Royal College of Psychiatrists, • Section 12(2) approval, Approved Clinician status, • Being on the Specialist Register for Forensic Psychiatry is highly desirable, • Experience of assessment and management of patients in forensic psychiatric settings., • Competitive Salary, • Car allowance, • 30 days annual leave plus bank holidays and your birthday off! (Pro-rata for less than full time), • Free meals and parking, • Wellbeing support and activities to help you maintain a great work-life balance., • Access to Wagestream, to help you manage your finances, • 24 hour GP Service to ensure you are the best you can be, • Career development and training to help you achieve your career goals., • Pension contribution to secure your future., • Medical indemnity cover, • Life Assurance for added peace of mind. About your next employer You will be working for an established, stable and agile company with over 8,000 employees and a unique approach to the delivery of care. With a network of over 90 services across England and Wales covering Mental Health, Neurological, Learning Disabilities & Autism, Children & Education, there is opportunity for you to grow and move. Elysium Healthcare is part of Ramsay Health Care with a global network that extends across 10 countries and employs over 86,000 people globally. Elysium Healthcare follows safer recruitment of staff for all appointments and is a Disability Confident employer, committed to inclusive and accessible recruitment. It is a requirement that all staff understand it is each person’s individual responsibility to promote and safeguard the welfare of service users. All candidates will be subject to a DBS disclosure.