About Us

Scendea is an international product development, regulatory, and compliance consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide.

Scendea’s expert team delivers strategic and operational support in the fields of Non-Clinical, CMC, Clinical and Regulatory to successfully guide products from early development to marketing approval. Our dedicated Compliance division strengthens development programmes through CRO & CDMO oversight, GxP audits, Quality Management System (QMS) support, and GxP training, ensuring robust quality frameworks and inspection readiness throughout the product lifecycle.

Job Description

Scendea is seeking a highly motivated individual to join ourglobal team as a permanent, full-time Senior Consultant (CMC). Thisis a hybrid position, affiliated to either our Australian, Brisbane office or UK Bishop's Stortford office , with arequirement to work in the office a minimum of one day per month.

This is an excellent opportunity to progressyour career at a rapidly growing product development, regulatory, and compliance consulting group. You will have theopportunity to play a key role in the development and mentoring of staff whilstproviding high-quality regulatory technical advice and product development.

Role Requirements

- Providestrategic, technical and regulatory advice/services to clients with aspecial interest in Chemistry, Manufacturing, and Controls (CMC) development of human medicinal products.
- Establishand maintain a high level of technical knowledge in product developmentand international regulatory affairs.




- Provideinnovative drug development plans, data gap analyses and internationalregulatory strategies from a CMC perspective for complex products withinthe changing regulatory environment.
- Contributeto technical authorship and review of development regulatory documentsincluding Regulatory Strategy Plans, Drug Development Plans, ClinicalTrial Applications, Pre-INDs, INDs, Scientific Advice and Meeting BriefingDocuments, Paediatric plans/applications, Investigator Brochures, IMPDs,Marketing Authorisation Applications, New Drug Applications, BiologicLicense Applications, DMFs according to area of expertise.
- Leadmulti-jurisdiction programs of work and deliver consulting services withinyour respective area of expertise.
- Representclients in regulatory agency interactions and provide regulatory solutionsto agency objections.
- Ensuredelivery of project goals within agreed timelines, maintaining oversightof project budgets.
- Leadmeetings with internal and external stakeholders on matters related to anycurrent and/or future projects, contracts, or recent business opportunities.
- SupportScendea's Business Development in sales/marketing introductions and generateadditional business from current clients.
- Linemanage, train,



and mentor members of the Scendea Operational team, includingproviding technical leadership.

Skills and Experience

- Ahigh scientific calibre with a relevant science focused BSc (orequivalent), and a higher degree in a biomedical field or equivalent(e.g., a life/physical science focused MSc or preferably a PhD).
- Aminimum of 5 years drug development experience.
- Aminimum of 5 years regulatory experience, working with either the TGA, FDA,MHRA, and/or EMA submissions, including meetings/negotiation. Regulatoryexperience may include time within a National Competent Authority.
- Authoring of CMC sections of regulatory documentation is required. MAA/BLA Experience is highly desirable.
- Demonstratedexperience with a broad range of products, including recombinant proteins andpeptides (including antibodies), prophylactic and therapeutic vaccines,biosimilar products, advanced therapy medicinal products (tissue, cell andgene therapy), RNA or DNA based products, live biotherapeutics and smallmolecule NCE and/or generic chemical entities.
- Directexperience preferred in providing strategic regulatory planning from early-stagedevelopment up to marketing authorisation, and a proven ability to defineand deliver creative scientifically driven solutions to technicaldevelopment and regulatory issues.
- Provenability and willingness to lead a team and deliver education and training inchosen field, both internally, and at scientific conference presentations.
- Exemplaryorganisational and time management skills with a high level of attentionto detail, and the proven ability to

📌 Senior Consultant (Brisbane)
🏢 Scendea
📍 Brisbane