Senior Regulatory Consultant (Clinical) in Watford

The Role

Scendea is seeking a highly motivated individual to join our global team as a full-time Consultant/Senior Consultant (Clinical).

This position is affiliated to our Bishop's Stortford, UK Office, with some opportunity to work remotely.

The ideal candidate will have established experience in working independently on a range of clinical development topics in compliance with current regulatory requirements.

They will need to be competent in direct hands-on clinical writing and review of documents for regulatory submissions.

This is an excellent opportunity to progress your career at a rapidly growing product development, regulatory, and compliance consultant 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 strategies for clients.

• Role Requirements
• Provide strategic, technical and regulatory advice/services to clients with a special interest in Clinical 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 Clinical 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 Ph D).
• A minimum of two years (Consultant) and a minimum of 5 years (Senior Consultant) of employment-related experience in drug development.
• A minimum of two years (Consultant) and a minimum of 5 years (Senior Consultant) of regulatory experience, working with either TGA, FDA, EMA, and/or MHRA submissions.
• Experience in project management and proven ability to balance competing priorities and complete work within a set timeframe.
• Demonstrated clinical development experience across a range of therapeutic indications/disease areas.
• 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.
• The Company

Scendea is an international product development, regulatory, and compliance 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 US, UK, Netherlands, and Australia, Scendea is undergoing a period of significant growth, with the addition of new service lines to facilitate the delivery of expert and strategic global regulatory and compliance 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.

Benefits Package

• A competitive salary.
• Generous bonus program, which rewards success.
• 26 days’ annual leave entitlement plus public holidays and discretionary additional days leave for birthday and work anniversaries.
• 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.
• 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.