Associate Consultant Toxicology

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).