Consultant - Netherlands

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 aim 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 its rapidly growing client base.

The Role

Scendea is seeking a Regulatory Affairs Consultant to join the global team in a full-time position, in our Netherlands office in Breda.

This exciting opportunity is ideal for someone with a minimum of 18 months regulatory experience who wants to progress their career in medical/scientific writing and regulatory consulting. At Scendea, we provide the training and guidance to enable you to deliver high-quality technical regulatory advice and product development strategies to our global clients whilst also supporting your professional growth within a highly professional, internationally recognised team.

Key Objectives

• Establishes and maintains a high level of technical knowledge in the area of product development and international regulatory affairs.
• Creates and delivers high-quality, billable product development and regulatory related documents.
• Develops strategic drug development strategies in the area of regulatory and employee’s specific area of expertise.
• Manages projects and provides practical support within company systems to ensure the timely completion of all project tasks within timelines and budgets.
• Perform literature/data searches and collate/summarise.
• Assess and analyse scientific data.
• Actively participates in meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts or new business opportunities to obtain relevant information and disseminates this information to internal and external stakeholders.
• Prepares written estimates, quotations and contracts for Clients as required.
• Ensure that all client material is treated and maintained in full respect of client confidentiality
• Supports training initiatives, onboarding, and Operational Excellence.

Location & Reporting Structure

The role will be full-time, home-based with the requirement to work in our Breda, Netherlands office a minimum of 3 days per week.

The selected candidate will report directly to a more senior team member.

Skills and Experience

• A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree (e.g., a life science focused MSc or PhD).
• Minimum of 18 months employment related experience in regulatory.
• Minimum of 18 months experience with regulatory authorities in either UK, Europe, or USA.
• Completion of an Industry specific course would be advantageous.
• Experience in successfully managing multiple projects for regulatory activities/ area of discipline.
• Experience with regards to medical/scientific writing would be a major positive for this position.
• A strong awareness of drug development and medical/regulatory affairs.
• Ability to work in a proactive and autonomous manner as well as being part of a team.
• Ability to balance competing priorities and complete work within a set timeframe.
• Good organisational skills with a high level of attention to detail.
• Excellent writing skills in English – you will be expected to summarise complex scientific data, thus facilitating the review of such data by external parties.
• Well-developed verbal communication and presentation skills In English.
• High level of computer literacy and competency in MS Office programs.
• Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the Netherlands, and or internationally.
• A clear ambition to progress your career in medical/scientific writing and regulatory consulting.
• Commercial experience is not a prerequisite for this position.

Company Aspirations

Scendea has grown two-fold in the last two years, with plans to expand the team by a further 20 team members this year. Our expansion plans include additional hires in the Netherlands, Australia, USA, UK and beyond. The leadership team continue to be dedicated to developing a great company culture through initiatives such as the Scendea Academy, Values Engagement and Internal Community Knowledge Creation of which the successful candidate will play a key role.

Benefits

• A competitive salary.
• Generous bonus program, which rewards success.
• 26 days’ vacation plus discretionary additional days for birthday and work anniversary and public holidays.
• 5% employer pension contribution.
• 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, wanting to contribute to a growing business and a rapidly expanding team.
• Coaching and mentoring to support your continuous learning, tailored to your individual needs.
• Support of your professional development within a highly professional, internationally recognised dynamic team.
• A unique working environment driven by strong company values and a very high level of employee engagement across the international organisation.

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.

Scendea Values

Excellence

We strive for excellence by challenging our approach, whilst having confidence in our abilities, showing determination to learn and grow.

Client Focused

We work closely with our clients, creating meaningful relationships and delivering best-in-class customer service to ensure mutual success.

Integrity

We act with honesty, transparency, and authenticity to inspire trust in our relationships.

Collaboration

We celebrate diversity, communicate effectively, and believe that together, we can achieve more.

Innovation

We encourage new ideas, curiosity and creativity, to foster a culture of continuous improvement.

Applicants must reside and be eligible to work in the Netherlands. Must not require sponsorship, and be in a reasonable commuting distance to the Breda office, a minimum of 3 days per week.