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About the Role
The Regulatory Operations Manager manages the regulatory operation process, including regulatory authority (RA) submissions and approvals, adhering to ICH-GCP guidelines, local regulatory requirements, Novotech/client standard operating procedures (SOPs), and project agreements.
Responsibilities
- Plan, prepare, review, and approve EC and RA applications for timely clinical trial approval.
- Review and approve proposed packaging and labeling for investigational products.
- Prepare, review, and submit importation and/or exportation licenses and/or permits for investigational products.
- Prepare, review, and approve essential documents such as Participant Information Sheets and Consent Forms.
- Review the Regulatory Green Light for Investigational Product Release package.
- Develop and maintain tracking to document work status and progress towards timelines for project teams.
- Monitor functional performance metrics.
- Participate in clinical services group activities, 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 a 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.
- Adhere to Company policies, procedures, and guidelines, maintaining quality in all duties.
- Identify areas of inefficiency and recommend improvements.
- Assist in the review and development of Novotech SOPs and guidelines.
- Participate in or lead company initiatives related to regulatory operations activities.
- Understand Novotech's responsibilities as a service provider in the pharmaceutical industry.
- Ensure all communications and study team performance present 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 EC/RA processes for clinical trials.
- Participate in bid preparation and meetings for clinical trial services with Novotech’s BD.
- Oversee external contractors performing marketing/registration regulatory work for Novotech.
- Represent Novotech at conferences and/or meetings.
Requirements
- Graduate in a clinical, pharmacy, or life-sciences related field within the CRO/pharmaceutical industry.
- At least 7 years of experience 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.
Experience Level
- At least 7 years’ experience
Education Level
- Graduate in a clinical, pharmacy or life-sciences related field
Benefits
- Flexible working options
- Paid parental leave for both parents
- Flexible leave entitlements
- Wellness programs
- Ongoing development programs
- NovoLife, our flexible benefits framework
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- At Novotech, ambition meets opportunity.
- As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth.
- Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.
- Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe.
- This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
- At Novotech, our employees are at the heart of our success.
- By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
- With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare.
- Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.
- At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market.
- This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences.
- At Novotech you will work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.
Equal Opportunity
- 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.
- 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.