Manager Regulatory Operations - Korean Nationals Only

Responsibilities

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• Act as line manager for all assigned RSA staff; Ensure line reports are aware and understand company policies and procedures appropriate to their position. Ensure resource and recruitment are well aligned and timely managed in collaboration with relevant parties, participate in interviews for potential new hires. Ensure utilization and realization targets for RSAs are met.

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• Work alongside line reports by oversight, planning, preparation, reviewing and approving of EC and RA applications to ensure timely approval of clinical trials. Review and approve proposed packaging and labelling for investigational products. Preparation, review, and submission of importation and/or exportation licences and/or permits for investigational products.

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• Manage and track status of work and progress towards timelines for all projects. Monitor functional performance metrics. Participate in activities of the clinical services group including project manager and clinical team training and meetings.

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• Represent Regulatory Start-up operations at client and project team meetings, providing input to start up timelines and study plans. Act as local regulatory expert to facilitate local or regional clinical trial regulatory and ethics submissions and approvals and regulatory intelligence. Participate or lead company initiatives related to regulatory start-up activities.

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• Provide advice to BD and/or project teams on regulatory start up strategy and any aspects of EC and/or RA process for clinical trials. Participate in bid preparation and meetings for clinical trial services in conjunction with Novotech’s BD where necessary.

Minimum Qualifications & 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 of working in the pharmaceutical industry or a related field.
• Clinical regulatory and start up knowledge and/or project management experience.
• CRO experience, line and/or matrix management experience are highly regarded.
• South Korea licensed Pharmacist highly regarded
• People Management experience is a must (more than 6 people team)

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.