The Role
Scendea is seeking a highly motivated individual to join our global team, full-time, as a Senior Consultant/ Consultant. This is a hybrid working position, affiliated to our Bishop's Stortford UK, office.
This is an excellent opportunity for an ambitious individual to progress their career at a rapidly growing Regulatory Consultancy, providing high-quality regulatory technical advice and product development strategies for our clients.
Role Requirements
- Provide strategic, technical, and regulatory advice/services to clients in all areas of the 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 non-clinical perspective for complex products within the changing regulatory environment.
- Contribute to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, IMPDs, CSRs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, according to area of expertise.
- Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
- Review written estimates, quotations, and contracts for Clients as required
- 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.
- Generate additional business from current Clients through exceeding expectations relating to the quality, delivery time and cost of services, and empower others to do the same
- 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.
- Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
Skills and Experience
- A high scientific calibre with a life science-focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science-focused MSc or preferably a PhD).
- A minimum of two years of drug development experience
- A minimum of two years of experience in regulatory with either FDA, MHRA, and/or EMA. Experience in project management and proven ability to balance competing priorities and complete work within a set timeframe.
- Ability and willingness to lead a small team and deliver internal mentorship, education and training in chosen field.
- 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
- A competitive salary.
- Generous bonus program, which rewards success.
- 26 days’ holiday plus discretionary additional days leave for birthday and work anniversary and public holidays.
- Employer pension contribution.
- Provision 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 the UK, without the requirement for sponsorship now or in the future. Closing date for applications is 10th Nov 2024 and candidates will be notified of the outcome of their application no later than 15th Nov 2024.
