Manager Regulatory Operations

About the role:
Regulatory Operations Manager – this role provides supervision, leadership, and line management of the Regulatory team. This role will ensure that line reports are trained and managed to regulatory process including regulatory authority (RA) and approval according to ICH-GCP guidelines, local regulatory requirements, Novotech / client standard operating procedures (SOPs), and the Project Agreement
Regulatory Operations Manager – this role will contribute to training of staff and may have responsibility for 1-2 layers of line reports in future.

Minimum Qualifications & Experience:

Graduate in a clinical, pharmacy or life-sciences related field and/or line management experience within the pharmaceutical industry. 

Regulatory Operations Manager: At least 7 years’ experience of working in the pharmaceutical industry or a related field. Clinical regulatory knowledge and/or project management experience. CRO experience, line and/or matrix management experience are highly regarded.

Responsibilities:

Project Execution and Delivery

• 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 licenses 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 study plans.
• Act as local regulatory expert to facilitate local or regional clinical trial regulatory submissions and approvals and regulatory intelligence.
• Establish and maintain relationships with local third-party vendors for regulatory (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 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.
• 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 strategy and any aspects of 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. 
• Oversee the process of conducting site identification assessment to evaluate the suitability of potential sites and help Project Management to define criteria and requirements for site selection based on study protocols, disease prevalence, regulatory considerations. 
• Review protocols, clinical trial documents, and regulatory guidelines to understand the study objectives, eligibility criteria, endpoints, and other relevant details. 
• Oversight and manage confidentiality process to ensure Confidentiality Agreements are in place prior to study discussions.

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 strategy and any aspects ofRA 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. 

  Work closely with the Japan Leadership:

• to support the design and development of Japan’s core functional capabilities
• to develop the hiring strategy for roles required Japan, ensuring alignment with organizational priorities and growth plans
• to promote and articulate Japan’s capabilities and value proposition to customers, strengthening our market presence and supporting business expansion
• to design and refine Japan’s delivery model to ensure operational excellence, scalability, and alignment with global standards

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.

• Act as line manager for one or more assigned staff; serve as a designated mentor to assigned regulatory start-up 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.
• Liaise with the Clinical Services management team and Learning and Development as necessary, to address individual learning requirements for line reports and contribute to the delivery to and training of staff.
• 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.
• Review and approve internal expenses within company policy.
• Ensure staff utilisation levels are maintained.
• Review and approval of timesheets of direct reports.

• 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.
• 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 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.
• 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).

• 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.

• 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.

• Develop strategic plans and objectives for site identification activities in alignment with the organizational goals and objectives.
• Lead a team of site identification specialists/administrators and provide guidance, direction, and support to team members to ensure effective execution of site identification activities.
• Oversee the process of conducting site identification assessment to evaluate the suitability of potential sites and help Project Management to define criteria and requirements for site selection based on study protocols, disease prevalence, regulatory considerations.
• Review protocols, clinical trial documents, and regulatory guidelines to understand the study objectives, eligibility criteria, endpoints, and other relevant details.
• Establish and maintain site data collection to build knowledge and intelligence.
• Work cross-functionally with other departments (e.g. Client Operations, Project Management, Quality Assurance) to collect intelligence on sites. Liaise with in-Country Leadership to collect country specific data to support site identification including country profile of sites and standard of care.
• Oversight and manage confidentiality process to ensure Confidentiality Agreements are in place prior to study discussions.
• Undertake other reasonably related site identification duties as may be assigned resources from time to time.
• Implement continuous improvement initiatives to enhance the efficiency, accuracy, and effectiveness of site identification assessment process. Solicit feedback from stakeholders, monitor industry best practices, and leverage technology solutions to optimise site identification and feasibility assessment efforts.

In addition to the above:

• Contribute to training of staff and have responsibility for 1-2 layers of line reports.
• To support or ensure that revenue recognition and realization related regulatory and start-up activities are well maintained.
• To support and promote the Novotech Mission and Vision.

Graduate in a clinical, pharmacy or life-sciences related field and/or line management experience within the pharmaceutical industry.

• 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.

• At least 7 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.

• At least 3 years line management experience within the CRO industry.