Our clientis seeking an experienced and highly motivated Small Molecule CMC Principal / Directorto join a growing regulatory and product development consulting team. This role is focused on Chemistry, Manufacturing and Controls (CMC) strategy for small molecule pharmaceutical products and offers the opportunity to work with a diverse portfolio of development-stage and commercial products across global markets.

The successful candidate will provide scientific, technical, and regulatory leadership to clients while supporting business growth, mentoring colleagues, and contributing to complex international development programmes.

This position offers a flexible hybrid working model with occasional travel as required.

Key Responsibilities:

- Provide strategic CMC consultancy and regulatory guidance for small molecule drug development programmes.
- Develop and deliver integrated CMC development strategies covering process development, manufacturing, scale-up, control strategies, and lifecycle management.
- Conduct gap assessments and identify regulatory pathways to support efficient product development and registration.
- Author, review, and contribute to a wide range of regulatory and technical documentation, including:
- Regulatory strategy documents
- Development plans
- Clinical trial applications
- IND and related submission packages
- Scientific advice briefing documents
- Investigator brochures
- IMPDs
- Marketing authorisation applications
- New drug applications
- Drug master files and supporting CMC documentation

- Lead complex, multi-region projects and ensure delivery of high-quality consulting services within agreed timelines and budgets.
- Represent clients during interactions with health authorities and provide strategic responses to regulatory questions and deficiencies.
- Collaborate with cross-functional stakeholders to drive project success and maintain strong client relationships.
- Support business development activities through proposal development, client meetings, and identification of new opportunities.
- Provide leadership,



coaching, and technical mentorship to junior and mid-level team members.
- Contribute to internal capability development, training initiatives, and knowledge-sharing activities.

Candidate Profile

Education:

- Bachelor’s degree in a scientific discipline (or equivalent).
- Advanced degree preferred (MSc, PhD, or equivalent) in pharmaceutical sciences, chemistry, life sciences, or a related field.

Experience:

- Significant experience in CMC development and regulatory strategy for small molecule pharmaceutical products.
- Approximately 10+ years of experience supporting pharmaceutical development, manufacturing, and regulatory activities.
- Solid understanding of global regulatory requirements, including FDA, EMA, MHRA, ICH, and GMP expectations.
- Experience across multiple dosage forms and product development stages, from early development through commercialisation.
- Demonstrated success preparing and supporting regulatory submissions and health authority interactions.
- Experience leading multidisciplinary projects and managing client relationships.
- Prior consulting experience is advantageous but not essential.

Skills:

- Strong scientific and technical expertise in pharmaceutical development and CMC.
- Excellent regulatory writing and document review skills.
- Proven leadership, mentoring, and team development capabilities.
- Strong organisational and project management skills.
- Excellent verbal and written communication abilities.
- Ability to work independently while collaborating effectively within global teams.
- Comfortable operating in a fast-paced, client-focused environment.
- Willingness to travel occasionally for client and project requirements.

Ideal Candidate

You are a scientifically driven CMC professional who combines deep technical expertise with commercial awareness and strong interpersonal skills. You enjoy solving complex development and regulatory challenges, building trusted client relationships, and supporting the growth and development of colleagues while contributing to the success of a energetic consulting business.

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📌 Small Molecule CMC Principal / Director (Queensland)
🏢 Planet Pharma
📍 Queensland