The Role

Scendea is seeking a highly motivated individual to join our
global team as a full-time Senior Consultant (CMC). This
is a hybrid position, affiliated to our Brisbane Australia office, with a
requirement to work in the office a minimum of one day per month.

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

Requirements

Role Requirements

- Provide
strategic, technical and regulatory advice/services to clients with a
special interest in Chemistry, Manufacturing, and Controls (CMC) development of human medicinal products.

- Establish
and maintain a high level of technical knowledge in product development
and international regulatory affairs.

- Provide
innovative drug development plans, data gap analyses and international
regulatory strategies from a CMC perspective for complex products within
the changing regulatory environment.

- Contribute
to technical authorship and review of development regulatory documents
including Regulatory Strategy Plans, Drug Development Plans, Clinical
Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing
Documents, Paediatric plans/applications, Investigator Brochures, IMPDs,
Marketing Authorisation Applications, New Drug Applications, Biologic
License Applications, DMFs according to area of expertise.

- Lead
multi-jurisdiction programs of work and deliver consulting services within
your respective area of expertise.

- Represent
clients in regulatory agency interactions and provide regulatory solutions
to agency objections.

- Ensure
delivery of project goals within agreed timelines, maintaining oversight
of project budgets.

- Lead
meetings with internal and external stakeholders on matters related to any
current and/or future projects, contracts, or new business opportunities.

- Support
Scendea's Business Development in sales/marketing introductions and generate
additional business from current clients.

- Line
manage, train, and mentor members of the Scendea Operational team, including
providing technical leadership.

Skills and Experience

- A
high scientific calibre with a relevant science focused BSc (or
equivalent),



and a higher degree in a biomedical field or equivalent
(e.g., a life/physical science focused MSc or preferably a PhD).

- A
minimum of 5 years drug development experience.

- A
minimum of 5 years regulatory experience, working with either the FDA, TGA, MHRA, and/or EMA submissions, including meetings/negotiation. Regulatory
experience may include time within a National Competent Authority.

- Authoring of CMC sections of regulatory documentation is required. MAA/BLA Experience is highly desirable.

- Demonstrated
experience with a broad range of products, including recombinant proteins and
peptides (including antibodies), prophylactic and therapeutic vaccines,
biosimilar products, advanced therapy medicinal products (tissue, cell and
gene therapy), RNA or DNA based products, live biotherapeutics and small
molecule NCE and/or generic chemical entities.

- Direct
experience preferred in providing strategic regulatory planning from early-stage
development up to marketing authorisation, and a proven ability to define
and deliver creative scientifically driven solutions to technical
development and regulatory issues.

- Proven
ability and willingness to lead a team and deliver education and training in
chosen field, both internally, and at scientific conference presentations.

- Exemplary
organisational and time management skills with a high level of attention
to detail, and the proven ability to work both proactively and autonomously.

- High
level of verbal communication and presentation skills in English, computer
literacy, and competency in MS Office programs.

- Willingness
to work flexible schedule and travel for short periods, sometimes at short
notice, within the country of employment, or internationally.

Benefits

Benefits Package

- A
competitive salary.

- Generous
bonus program, which rewards success.

- 26
days’ holiday plus discretionary additional days for birthday and work
anniversary and public holidays.

- Compensation towards Superannuation





- Compensation towards Private Healthcare insurance.

- Access
to Employee Assistance Programme.

- Employee
Ownership Trust Scheme.

- A
challenging and stimulating position for a dynamic and competent
scientist, looking to contribute to a growing business and a rapidly
expanding team.

- Coaching,
mentoring and support of your continuous learning, and professional
development within a highly recognised international team.

The Company

Scendea is an international product development and
regulatory consulting group delivering market-leading scientific expertise
& regulatory solutions, to advance healthcare innovation worldwide. We are
passionate about delivering strategic and operational support to clients, with
a strong commitment to problem-solving and redefining customer service. Our goal
is to streamline the product development process, reduce time-to-market, and
minimise overall development costs.

With a current team of over 50 staff based in the UK,
Netherlands, Australia, and the US, Scendea is undergoing a period of
significant growth, with the addition of new office locations and service lines
to facilitate the delivery of expert and strategic global regulatory consulting
services to our rapidly growing client base. We are equally committed to making
a positive impact on society by managing our environmental impacts and
contributing to a low-carbon economy. Our inclusive work culture values transparency,
ethical collaboration with clients, and employee involvement in key
decision-making processes, ensuring that our team is respected, supported, and
engaged.

As a Scendea Employee

Part of what makes Scendea successful is the highly
motivated people who work for us and their enthusiasm for what we do and stand
for. We recruit individuals whose passion, drive, integrity and customer
orientation shines through. You are a motivated individual who can instil trust
and confidence in our customer relationships whilst having a natural aptitude
for getting the best out of people internally. You will inspire others through
your commitment, motivation, expertise, professional manner and always placing
the customer at the centre of everything you do.

Eligibility & Conditions

Applicants must reside and be eligible to work inAustralia without the requirement for sponsorship now or in the future.

📌 Senior Consultant (CMC Small Molecules) AUS (Milton)
🏢 Important Group
📍 Milton