The Senior or Principal Consultant within Novotech Drug Development Consulting (DDC) will provide strategic regulatory and product development advice to internal and external stakeholders and manage client projects. The role will support development programs from early development through clinical development and marketing application activities across multiple regulatory jurisdictions.

The successful candidate will develop and implement regulatory strategies, provide high-quality regulatory advice, prepare and critically review regulatory documents and submissions, and lead or support interactions with Regulatory Authorities. The role requires the ability to translate regional regulatory requirements into practical development strategies and to identify regulatory risks, dependencies, and areas requiring early resolution.

The successful candidate will demonstrate robust regulatory judgment, strategic thinking, client leadership, and the ability to work effectively across functions and regions. The individual must be able to manage multiple priorities, communicate proactively, identify and escalate risks early, and consistently deliver high-quality work with an appropriate level of independence for the position.

This position may be appointed at the Senior Consultant or Principal Consultant level based on the candidate's experience and demonstrated level of regulatory strategy leadership and independence.

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

Responsibilities include:

- Develop and provide strategic regulatory advice to clients across the product development lifecycle, including development of regional and global regulatory strategies.

- Lead or contribute to regulatory strategy integrating APAC, U.S., EU, and other applicable regional requirements, identifying differences, risks, dependencies, and practical development options.

- Prepare, review,



and critically assess high-quality regulatory documents and submissions, including clinical trial applications, INDs, Regulatory Authority meeting packages, responses to Regulatory Authority questions, and other development and lifecycle submissions.

- Lead and participate in interactions with Regulatory Authorities, including development of meeting strategy, preparation of briefing materials and questions, meeting participation, and assessment and implementation of regulatory feedback.

- Independently manage client projects, including scope, timelines, deliverables, budget awareness, resource coordination, client expectations, and proactive communication of project status and risks.

- Provide strong client-facing leadership, including communicating complex regulatory issues clearly, providing practical recommendations, setting expectations, and escalating significant risks or issues early.

- Critically review regulatory, scientific, and development documentation to identify inconsistencies, gaps, and risks and ensure alignment with agreed regulatory strategy and prior Regulatory Authority feedback.

- Work effectively across clinical, CMC, nonclinical, medical writing, statistics, and other disciplines to develop integrated regulatory strategies and ensure high-quality, timely delivery of client work.

- Support business development activities through regulatory input to proposals, client discussions, scope development, and identification of opportunities to provide additional value to existing and prospective clients.

- Build strong collaborative relationships with clients,



Regulatory Authorities, internal stakeholders, and cross-functional project teams.

Required Experience and Qualifications:

Senior Consultant

- Minimum 6 years of relevant regulatory affairs experience.

- Demonstrated ability to independently manage regulatory activities and client projects, with senior support available for particularly complex or novel global strategy decisions.

Principal Consultant

- Minimum 12 years of relevant regulatory affairs experience.

- Demonstrated ability to independently develop and lead complex global regulatory strategy, manage high-complexity client programs, and provide senior regulatory leadership with limited oversight.

For both levels

- Strong APAC regulatory expertise, with demonstrated ability to independently develop and lead regional regulatory strategy.

- Strong knowledge of U.S. regulatory requirements, including experience leading or contributing to IND development, Regulatory Authority meeting strategy, lifecycle management, and other U.S. submissions.

- Demonstrated experience contributing to or leading global regulatory strategy across multiple regions.

- Excellent regulatory writing and critical review skills, with the ability to identify strategic, scientific, and regulatory inconsistencies and ensure documents align with Regulatory Authority feedback and agreed regulatory strategy.

- Strong client-facing communication, judgment, and problem-solving skills.

- Demonstrated ability to manage multiple high-priority projects and deliverables in a consulting or similarly fast-paced environment.

- Strong cross-functional leadership, ownership, and execution, including effective engagement with clinical, CMC, nonclinical, medical writing, statistics, and other subject matter experts.

- Degree in a relevant scientific, clinical, pharmacy, or life sciences discipline, or equivalent relevant experience.

📌 Regulatory Consultant - Drug Development Consulting - Australia (Sydney)
🏢 Novotech
📍 Sydney