**Brief Position Description**Associate Regulatory Operations Manager - this role provides supervision, leadership, and line management of the Regulatory Start up team. This role will ensure that line reports are trained and managed to regulatory authority (RA) and ethics committee (EC) submissions and approval according to ICH-GCP guidelines, local regulatory requirements, Novotech / client standard operating procedures (SOPs), and the Project Agreement.Associate Regulatory Operations Manager - this role will contribute to training of staff and Senior Regulatory Operations Manager may have responsibility for 1-2 layers of line reports.**Minimum Qualifications and Experience**Graduate in a clinical, pharmacy or life-sciences related field and/or line management experience within the pharmaceutical industry. At least 10 years' experience within the pharmaceutical, biotechnology or CRO industry is preferred including at least 3 years in a people management role.At least 5 years' experience of working in the pharmaceutical industry or a related field. Clinical regulatory and start up knowledge and/or project management experience. Previous mentoring or staff supervision experience desirable.**Responsibilities****Line Management**- Act as line manager for one or more assigned RSAs, SRSAs; serve as a designated mentor to assigned regulatory operations staff.- Ensure induction process is completed as per company policy for all line reports on commencement of employment with the organisation.- Ensure line reports are aware and understand company policies and procedures appropriate to their position.- Meet regularly (in probation weekly or bi-weekly upon LM's decision, moving to a minimum of monthly) with line reports to review their workload, welfare, and developmental needs.- Set and agree written goals and objectives, perform annual appraisal interviews and end of probation appraisals; submit promotion requests to management as appropriate.- Ensure management is aware of line report performance progress and informed of any issues arising.- Ensure performance reviews take place in accordance with company procedures.- Maintain promotion and succession plan for own teams.- Review and approve leave requests for line reports in line with company policy.- Ensure resource and recruitment are well aligned and timely managed in collaboration with relevant parties, participate in interviews for potential new hires.- Actively seek feedback and monitor the quality of line reports work on an ongoing basis.- Liaise with the Clinical Operations management team, Learning and Development and RSAs as necessary, to address individual learning requirements for line reports- Participate in activities of the Regulatory Start up department, including presentation at regulatory start up team meetings and, attendance at company meetings and contributing to the development of regulatory start up processes and SOPs.**Finance**- Review and approve internal expenses within company policy.- Ensure staff utilisation levels are maintained.- Review and approval of timesheets of direct reports**Project Execution and Delivery**- Review and approve proposed packaging and labelling for investigational products.- Preparation, review, and submission of importation and/or exportation licenses and/or permits for investigational products.- Preparation, review, and approval of essential documents such as Participant Information Sheets and Consent Forms.- Review and approval of Project/Country/Site Activations for Investigational Product Release.- Develop and maintain tracking to ensure status of work and progress towards timelines is clearly documented and available to project teams. Monitor functional performance metrics.- Participate in activities of the clinical operations group including project manager and clinical team training and meetings.- Represent Regulatory Start-up operations at client and project team meetings, providing input to start up timelines and study plans.**Learning & Development**- Identify learning and development needs of staff.- Contribute to the delivery and training of staff.**General**- Adhere to Company policies, procedures and guidelines and be quality minded in performance of duties.- Identify areas of inefficiency and make recommendations for improvements.- Assist in the review and development of Novotech SOPs and guidelines.- Participate or lead company initiatives related to regulatory start-up activities.- Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry.- Ensure all communications with external parties and the performance of the study team presents a positive professional image of the company.
