Manager Regulatory Operations - Japan

The role of Regulatory Operations Manager manages the regulatory operation process including regulatory authority (RA) submissions and approval according to ICH-GCP guidelines, local regulatory requirements, Novotech / client standard operating procedures (SOPs), and the project agreement. 

About the Role

Project Execution and Delivery

• 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.
• Preparation, review, and approval of essential documents such as Participant Information Sheets and Consent Forms.
• Review of Regulatory Green Light for Investigational Product Release package.
• 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 services group including project manager and clinical team training and meetings.
• Represent regulatory 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.
• Establish and maintain relationships with local third-party vendors for regulatory start-up (e.g., Central laboratories, drug distribution depot, couriers, local regulatory consultants, and translators).

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 operations 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.

Business Development

• Understand local trial conditions and advise Operations and Business Development (BD) of any developments.
• Identify opportunities to expand Novotech business within existing projects.
• 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.
• Oversight of external contractors who perform marketing/registration regulatory work for Novotech.
• Represent Novotech at conferences and/or meetings.

Minimum Qualifications & Experience

• Graduate in a clinical, pharmacy or life-sciences related field within the CRO/pharmaceutical industry.
• At least 7 years’ experience of working in the CRO/pharmaceutical industry or a related field. Clinical regulatory knowledge and/or project management experience. CRO experience, and/or matrix management experience are highly regarded.

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 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 contacting you regarding your application.