Job Description
The Role
n
Scendea is seeking a highly motivated individual to join our
n global team as a full-time Senior Consultant (CMC). This
n is a hybrid position, affiliated to our Brisbane Australia office, with a
n requirement to work in the office a minimum of one day per month.
n
This is an excellent opportunity to progress
n your career at a rapidly growing product development, regulatory, and compliance consulting group. You will have the
n opportunity to play a key role in the development and mentoring of staff whilst
n providing high-quality regulatory technical advice and product development.
n
Requirements
n
Role Requirements
n
n
Provide
n strategic, technical and regulatory advice/services to clients with a
n special interest in Chemistry, Manufacturing, and Controls (CMC) development of human medicinal products.
n
Establish
n and maintain a high level of technical knowledge in product development
n and international regulatory affairs.
n
Provide
n innovative drug development plans, data gap analyses and international
n regulatory strategies from a CMC perspective for complex products within
n the changing regulatory environment.
n
Contribute
n to technical authorship and review of development regulatory documents
n including Regulatory Strategy Plans, Drug Development Plans, Clinical
n Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing
n Documents, Paediatric
plans/applications,
Investigator Brochures, IMPDs,
n Marketing Authorisation Applications, New Drug Applications, Biologic
n License Applications, DMFs according to area of expertise.
n
Lead
n multi-jurisdiction programs of work and deliver consulting services within
n your respective area of expertise.
n
Represent
n clients in regulatory agency interactions and provide regulatory solutions
n to agency objections.
n
Ensure
n delivery of project goals within agreed timelines, maintaining oversight
n of project budgets.
n
Lead
n meetings with internal and external stakeholders on matters related to any
n current and/or future projects, contracts, or new business opportunities.
n
Support
n Scendea's Business Development in sales/marketing introductions and generate
n additional business from current clients.
n
Line
n manage, train, and mentor members of the Scendea Operational team, including
n providing technical leadership.
n
n
Skills and Experience
n
n
A
n high scientific calibre with a relevant science focused BSc (or




n equivalent), and a higher degree in a biomedical field or equivalent
n (e.g., a life/physical science focused MSc or preferably a PhD).
n
A
n minimum of 5 years drug development experience.
n
A
n minimum of 5 years regulatory experience, working with either the FDA, TGA, MHRA, and/or EMA submissions, including
meetings/negotiation.
Regulatory
n experience may include time within a National Competent Authority.
n
Authoring of CMC sections of regulatory documentation is required. MAA/BLA Experience is highly desirable.
n
Demonstrated
n experience with a broad range of products, including recombinant proteins and
n peptides (including antibodies), prophylactic and therapeutic vaccines,
n biosimilar products, advanced therapy medicinal products (tissue, cell and
n gene therapy), RNA or DNA based products, live biotherapeutics and small
n molecule NCE and/or generic chemical entities.
n
Direct
n experience preferred in providing strategic regulatory planning from early-stage
n development up to marketing authorisation, and a proven ability to define
n and deliver creative scientifically driven solutions to technical
n development and regulatory issues.
n
Proven
n ability and willingness to lead a team and deliver education and training in
n chosen field, both internally, and at scientific conference presentations.
n
Exemplary
n organisational and time management skills with a high level of attention
n to detail, and the proven ability to work both proactively and autonomously.
n
High
n level of verbal communication and presentation skills in English, computer
n literacy, and competency in MS Office programs.
n
Willingness
n to work flexible hours and travel for short periods, sometimes at short
n notice, within the country of employment, or internationally.
n
n
Benefits
n
Perks
Package
n
n
A
n competitive salary.
n
Generous
n bonus program, which rewards success.
n
26
n days' holiday plus discretionary additional days for birthday and work
n anniversary and public holidays.
n
Compensation towards Superannuation
n




Compensation towards Private Healthcare insurance.
n
Access
n to Employee Assistance Programme.
n
Employee
n Ownership Trust Scheme.
n
A
n challenging and stimulating position for a dynamic and competent
n scientist, looking to contribute to a growing business and a rapidly
n expanding team.
n
Coaching,
n mentoring and support of your continuous learning, and professional
n development within a highly recognised international team.
n
n
The Company
n
Scendea is an international product development and
n regulatory consulting group delivering market-leading scientific expertise
n & regulatory solutions, to advance healthcare innovation worldwide. We are
n passionate about delivering strategic and operational support to clients, with
n a strong commitment to problem-solving and redefining customer service. Our goal
n is to streamline the product development process, reduce time-to-market, and
n minimise overall development costs.
n
With a current team of over 50 staff based in the UK,
n Netherlands, Australia, and the US, Scendea is undergoing a period of
n significant growth, with the addition of new office locations and service lines
n to facilitate the delivery of expert and strategic global regulatory consulting
n services to our rapidly growing client base. We are equally committed to making
n a positive impact on society by managing our environmental impacts and
n contributing to a low-carbon economy. Our inclusive work culture values transparency,
n ethical collaboration with clients, and employee involvement in key
n decision-making processes, ensuring that our team is respected, supported, and
n engaged.
n
n
As a Scendea Employee
n
Part of what makes Scendea successful is the highly
n motivated people who work for us and their enthusiasm for what we do and stand
n for. We recruit individuals whose passion, drive, integrity and customer
n orientation shines through. You are a motivated individual who can instil trust
n and confidence in our customer relationships whilst having a natural aptitude
n for getting the best out of people internally. You will inspire others through
n your commitment, motivation, expertise, professional manner and always placing
n the customer at the centre of everything you do.
n
n
Eligibility & Conditions
n
Applicants must reside and be eligible to work inAustralia without the requirement for sponsorship now or in the future.
n

📌 Senior Consultant (Cmc Small Molecules) Aus (New South Wales)
🏢 Scendea
📍 New South Wales