Job Description
Senior Consultant & Team Lead
Location : Netherlands
Employment Type : Full-Time
Overview
An opportunity has opened for a motivated professional to take on a Senior Consultant & Team Lead role within a dynamic and fast-growing regulatory consultancy. Based in the Netherlands, the position offers a hybrid work environment, requiring a minimum of two days per week in the office. This role is ideal for an experienced regulatory professional eager to lead a high-performing team and provide strategic, technical, and regulatory expertise to a wide variety of clients.
Responsibilities
- Lead and manage the Netherlands operational team, ensuring smooth integration and alignment with the broader global organization.
- Act as the key liaison for the Netherlands team, providing updates, feedback, and escalations to the global operations leadership.
- Provide mentorship and technical guidance to junior team members in collaboration with the Technical Head for the Netherlands.
- Deliver strategic regulatory consulting services, including innovative drug development plans, regulatory strategies, and data gap analyses.
- Author and review critical regulatory documents such as clinical trial applications, scientific advice briefing packages, orphan drug applications, and marketing authorization submissions.
- Oversee and manage multi-jurisdictional projects, ensuring delivery within agreed timelines and budget parameters.
- Represent clients in regulatory interactions, providing solutions to address agency feedback or objections.
- Lead internal and external stakeholder meetings related to ongoing projects or business development opportunities.
- Play an active role in business development by generating additional opportunities with current and new clients.
- Fulfill health and safety responsibilities at the Netherlands location and contribute to the operational development of the local office.
Qualifications and Experience
A life sciences-focused BSc and an advanced degree (MSc or PhD preferred) in a biomedical field. A strong background in toxicology is essential.A minimum of 8-10 years of drug development experience, with direct involvement in regulatory negotiations with authorities such as EMA, FDA, or MHRA.Proven ability to create strategic regulatory plans for projects from early development through marketing authorization.Strong leadership skills, including team management and the delivery of internal training or external scientific presentations.Excellent organizational abilities with high attention to detail, capable of working proactively and independently.Proficiency in English, both written and verbal, and experience using MS Office tools.Flexibility to travel domestically or internationally on short notice.Benefits
Competitive salary with a generous performance-based bonus program.26 days of vacation, with additional discretionary days for birthdays and work anniversaries.5% employer pension contributions and private healthcare coverage.Access to employee wellness programs and ownership schemes.Opportunities for ongoing professional development through mentoring and training.About the Organization
The company is a globally recognized consultancy specializing in product development and regulatory strategies. With teams spanning multiple countries, they are dedicated to delivering high-quality solutions that accelerate innovation in healthcare. Their inclusive and collaborative culture emphasizes sustainability, employee involvement, and a commitment to client success.
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