The Role
Scendea is seeking a highly motivated individual to join our global team as a full-time Deputy Head of Product Development & Regulatory Consulting, at either Senior Consultant or Principal Consultant level. This is a hybrid position, affiliated to either our UK, Netherlands, US, or Australia office, with a requirement to work in the office a minimum of one day per month. The position reports to the Head of Product Development & Regulatory Consulting.
This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. 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 strategies for clients.
Role Requirements
- Support the Head of Product Development and Regulatory Consultancy in leading the Global Operational team and drive the implementation of best practice to ensure timely, high-quality client deliverables.
- Provide guidance and coaching, and remove obstacles to delivery, to enable the team to complete their project deliverables.
- Support the team with routine management guidance, and focused project specific account development and expansion advice.
- Provide strategic, high quality, technical and regulatory advice/services to facilitate the entry of Client’s compounds into clinical trials and assist in the activities required for successful international marketing approvals. Establish and maintain a high level of technical knowledge in product development and international regulatory affairs.
- Create and deliver high-quality billable regulatory related documentation for clients, contributing to the 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.
- Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets and adherence to processes and procedures
- 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 actively generates additional business from current clients.
- Line manage, train, and mentor members of the Scendea Operational team, including providing technical leadership.
- Support and coordinate the development and implementation of systems and procedures to ensure appropriate tools in place to support team utilisation, skills allocation, and the appropriate assignment of project work, and to drive operational efficiency initiatives and process improvements.
- Review and analyse identified issues to develop strategies for corrective and preventative actions, to ensure the continued provision of high-quality and timely project delivery, and to sustain long-term client partnerships.
- Assist in the development and maintenance of Standard Operating Procedures (SOPs) and other relevant training materials
- Review written estimates, quotations, and contracts and assists in the translation of these into executed contracts for Clients as required.
- Be an active participant of the senior leadership team to support achieving the company goals.
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 eight years (Senior Consultant level) or minimum of ten years (Principal Consultant level) of drug development experience.
- A minimum of eight years (Senior Consultant level) or minimum of ten years (Principal Consultant level) of regulatory experience, working with either the FDA, MHRA, EMA or TGA submissions, including meetings/negotiation. Regulatory experience may include time within a National Competent Authority.
- A minimum of 5 years direct/matrix management experience of a team/function.
- Human medicinal product development experience across a wide range of therapeutic indications/disease areas, with direct experience preferred in providing strategic regulatory planning from early-stage clinical 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 hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.
Benefits
- Generous bonus program, which rewards success.
- Generous holiday/vacation plus discretionary additional days for birthday and work anniversary and public holidays.
- Employer pension contribution/ compensation in line with country specific legislation.
- Provision of / compensation of 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 in either the UK/Netherlands/US/Australia without the requirement for sponsorship now or in the future. Closing date for applications is 13th June 2025 and candidates will be notified of the outcome of their application no later than 17th June2025.
