Senior Consultant - Medical Affairs

The Consultant within DDC will provide regulatory and product development support to Novotech stakeholders, both internal and external, including managing Clients’ projects. Primarily, activities will focus on work that facilitates the entry of and progression through  clinical trials of clients’ compounds. 

The Consultant will also assist with activities required to obtain marketing approval in multiple regulatory jurisdictions. Practically, this includes the drafting and review of regulatory documents such as briefing packages for meetings with regulatory agencies and clinical trial application documents e.g. INDs and license applications for genetically modified organisms (GMOs) and IBs. Additionally, this may include review and revision of primary technical documents.  Direct communication with Regulatory Authorities such as managing or attending scientific advice meetings will be required. The Senior Consultant will develop regulatory strategies in areas of the employee’s specific area of expertise and articulate these to potential and existing Clients.

The successful candidate will have a high degree of business acumen and strategic thinking, with the ability to see beyond the immediate technical task, understand broader client and business objectives, and develop pragmatic solutions that deliver scientific and commercial value.

This permanent role will be based in Australia, and you must have unrestricted working rights to be considered for this role. 

Responsibilities include: 

• 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. This includes negotiating realistic timelines with Clients, planning project timelines according to milestones and deliverables, organizing team members to assist with projects as required, ensuring timelines are met (unless there are extenuating circumstances), providing Clients with regular updates, ensuring deliverables are of high quality before being sent to Clients, 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 team 

Required Experience and qualifications: 

• 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).