Senior Consultant (CMC) Australia

Scendea Ltd; Brisbane; Hybrid; AUD 120,000 - 180,000; Full time

Benefits offered by this job

Generous bonus program

26 days annual leave

Employer pension contribution

Private healthcare insurance

Employee Assistance Programme

Employee Ownership Trust Scheme

Coaching and professional development

Job summary

Scendea Ltd. is seeking a Senior Consultant (CMC) to join our hybrid team, based in Australia (Brisbane) or the UK (Bishop's Stortford). You will provide strategic regulatory advice, lead CMC development plans, and coordinate global submissions while mentoring junior staff.

The role requires travel and periodic in-office work, with a minimum one day on-site per month. You will influence regulatory strategy from early development to marketing authorization, collaborate with clients, and deliver

Qualifications

• Requires a strong scientific background with hands-on drug development and CMC experience.
• Experience leading multi-jurisdiction regulatory programs and interacting with authorities.
• Proven ability to mentor staff and lead regulatory strategy across projects.

Responsibilities

• Provide strategic regulatory advice for CMC development of human medicines.
• Lead multi-country regulatory submissions and agency interactions.
• Manage project budgets and timelines, mentoring team members.
• Support business development through client engagements and proposals.

Skills

CMC development

Regulatory strategy

Technical leadership

Global submissions

Mentoring & training

English communication

Education

BSc in a biomedical field or equivalent

PhD in biomedical field (desirable)

Job description

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 new 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 work both proactively and autonomously.
• Highlevel of verbal communication and presentation skills in English, computerliteracy, and competency in MS Office programs.
• Willingnessto work flexible hours and travel for short periods, sometimes at shortnotice, within the country of employment, or internationally.

BenefitsPackage

• Generousbonus program, which rewards success.
• 26days’ Annual leave plus discretionary additional days for birthday, workanniversary and public holidays.
• Employer pension contribution / compensation in line with country specific legislation.
• Compensation of Private Healthcare insurance.
• Accessto Employee Assistance Programme.
• EmployeeOwnership Trust Scheme.
• Achallenging and stimulating position for a dynamic and competentscientist, looking to contribute to a growing business and a rapidlyexpanding team.
• Coaching,mentoring and support of your continuous learning, and professionaldevelopment within a highly recognised international team.

The Company

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.

A combination of scientific excellence, industry experience and a collaborative approach enables us to deliver high-quality innovative solutions, which allow our clients to succeed.

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

As a Scendea Employee

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

Eligibility & Conditions

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