The Associate Consultant within Novotech will provide scientific and product development support to Novotech stakeholders, both internal and external across a range of therapeutic modalities, including small molecules, biologics, cell and gene therapies, and other emerging technologies. Primarily, activities will focus on work that facilitates the entry of Client’s compounds into clinical trials. The Associate Consultant contributes to the interpretation of nonclinical data, preparation of regulatory documentation, development of clinical entry strategies, and delivery of sponsor-facing consulting services.
The Associate Consultant will also assist with activities required to obtain marketing/regulatory approval in multiple regulatory jurisdictions. The Associate Consultant will assist with drafting regulatory documents such as briefing packages for meetings with regulatory agencies and clinical trial application documents e.g. INDs and licence applications for genetically modified organisms (GMOs), as required.
This 12 month Contract role will be based in Australia.
Responsibilities include:
Assist in the preparation and review of:
Draft and contribute to regulatory documents and submission packages, including Investigator's Brochures, nonclinical overviews and summaries, IND/CTA-supporting documentation, regulatory briefing documents, clinical entry assessments, and nonclinical development plans.
Support responses to sponsor inquiries regarding toxicology strategy and regulatory expectations.
Collaborate with multidisciplinary teams including regulatory affairs, clinical development, pharmacology, CMC, therapeutic strategy and project management.
- Collate and track information for specific tasks performed by Drug Development Consulting staff e.g. clinical entry strategies and drug development plans
- Perform quality control checks of documents prior to finalization that are not performed by the QC Specialist
- Build strong relationships with internal and external stakeholders and other project team members to ensure high-quality work and timely delivery of documents
- Maintain confidentiality to operate in the role with the highest of ethical and quality standards
Daily demonstrate a positive, “can-do” and service-oriented attitude
Effective and prompt oral and written communication to collaborate and deliver an excellent product in a fast-paced, and rapidly growing dynamic company
Minimum Qualifications & Experience:
Post Doctoral Graduate qualifications will be an advantage.
PK/PD knowledge would be advantageous.
Minimum of one year of relevant experience in regulatory affairs.
Demonstrated industry experience in regulatory affairs for pharmaceutical products. Demonstrated ability to work effectively and independently in a fast-paced environment with multiple high priority projects under tight timelines.
Strong proficiency in English usage (both verbal and written with grammar, punctuation, language). Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction.
Experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
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.
Skills Required
- Minimum one year of relevant regulatory affairs experience
- Industry experience in regulatory affairs for pharmaceutical products
- Ability to work independently in a fast-paced environment with multiple high-priority projects and tight timelines
- Strong verbal and written English proficiency, including grammar, punctuation, and language
- Excellent customer-service orientation and professionalism
- Ability to work with limited direction
- Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint
- Postdoctoral graduate qualifications
- Pharmacokinetic and pharmacodynamic knowledge
What We Do
Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, "Novotech" and "PPC". Novotech is a full-service clinical CRO with labs, phase I facilities, and drug development consulting services.
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