Regulatory Compliance Manager

Almac Group is a global leader in advancing human health. We provide a range of expert services across the drug development lifecycle to pharmaceutical and biotech companies, supporting them in finding treatments for patients. Skills and Attributes Supervisory experience Knowledge of GMP Investigational Medicinal Products Description Regulatory Compliance Manager Hours: 37.5 hours per week Business Unit : Clinical Services Open To : Internal and External Applicants Ref No.: HRJOB10420 The Role The Regulatory Compliance Manager is responsible for the proactive review and assessment of forthcoming or recent regulatory changes to ascertain requirements and determine any necessary actions to ensure continued compliance. In doing so, they will support department managers in the facilitation of Change Control and Risk Assessment to ensure the smooth implementation of changes in line with agreed timelines. The Regulatory Compliance Manager also plays a key role in educating staff of the regulatory requirements they must comply with in order to recognize potential non-compliances and ensure new systems and processes are compliant. This proactive approach safeguards quality and helps ensure project timelines are met. Furthermore, the role involves preparing and cascading regular newsletters, training materials, escalating issues or concerns, and providing support during investigations, serving as a key point of contact for customers, regulatory agencies, and pharmaceutical forums regarding queries related to new regulations. Key Requirements Have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full-time employment in the UK Knowledge of GMP and current regulations Degree in a scientific discipline Regulatory knowledge of Investigational Medicinal Products Technical knowledge of Operational activities (production and distribution) undertaken by Almac Clinical Services Experience within a supervisory role Experience in Change Control and Risk Assessments Further Information After a successful probation period, the working pattern for this role is a flex pattern between the hours of 06:00 – 22:00 with a requirement of 5 hours minimum per day. This role will require coverage beyond normal working hours and international travel as and when required. Apply Now Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible. Closing Date We will no longer be accepting applications after 5pm on 25 February 2025 . RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CVs received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation. Almac Group is an Equal Opportunity Employer. #J-18808-Ljbffr