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About the Role
The Consultant will provide regulatory and product development support to Novotech stakeholders, managing client projects focused on facilitating the entry and progression of compounds through clinical trials. This role also involves assisting with marketing approval processes in multiple regulatory jurisdictions, including drafting and reviewing regulatory documents and communicating directly with regulatory authorities.
Responsibilities
- Draft and review regulatory documents such as those based on the Common Technical Document format, Investigational Brochures, and licence applications for GMOs.
- Review of technical documentation, as needed.
- Provide strategic drug development advice verbally and in writing to internal and external stakeholders as required.
- Manage DDC standalone projects or DDC sub-projects, including negotiating timelines, planning project timelines, organizing team members, ensuring timelines are met, providing client updates, ensuring deliverable quality, and reviewing invoices.
- Communicate directly with the Australian Therapeutic Goods Administration (TGA), Office of the Gene Technology Regulator (OGTR), the New Zealand Environmental Protection Agency (EPA) or other regulatory authorities, as required.
- Participate in teleconferences and face-to-face meetings with Clients.
- Review proposals generated by the Business Development team as required.
- Build strong relationships with internal and external stakeholders and other project teams.
Requirements
- Graduate or Post-graduate qualification in clinical, pharmacy or life sciences related field.
- Minimum of 3 years’ experience in Australian regulatory affairs or other relevant discipline related to the nonclinical development processes e.g. toxicology, chemistry, or CMC manufacturing, required to support development and approval of 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.
- Highly experienced in the use of MS Office (Outlook, Word, Excel, PowerPoint).
- Must have unrestricted working rights in Australia.
Skills
- Regulatory strategy development
- Product development support
- Clinical trial support
- Marketing approval processes
- Regulatory document drafting and review
- Communication with regulatory authorities
- Project management
- Business acumen
- Strategic thinking
- MS Office proficiency
Location
- Australia
Work Type
- Permanent
- Full-time
Experience Level
- Minimum of 3 years’ experience
Education Level
- Graduate or Post-graduate qualification in clinical, pharmacy or life sciences related field
Benefits
- Flexible benefits framework (NovoLife)
- Mentorship opportunities
- Professional development programs
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- Novotech is a globally recognized leader in clinical research and scientific advisory services.
- 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).
- Fostering an environment that reflects the life-changing work they do.
- Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
- Unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
- Employees are at the heart of their success.
- Offers trust, flexibility, and autonomy.
- Empowers team members to create an effective work-life balance.
- Provides a platform for driven individuals to achieve personal growth while shaping the future of healthcare.
- Has advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model.
- Offers employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture.
- Works with clients on the cutting-edge of life sciences.
- Empowered teams with a shared commitment to success.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.