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 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.
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.
Site Identification (if dedicated role the business title is Site Identification Manager)
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.
Minimum Qualifications & Experience
Graduate in a clinical, pharmacy or life-sciences related field and/or line management experience within the pharmaceutical industry.
Experience:
Associate Regulatory Operations Manager
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.
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.
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations.
Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years.
For more information or to speak to an expert team member visit www.Novotech-CRO.com
