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Senior Consultant & Team Lead

Senior Consultant & Team Lead

PharmiwebGroningen, NL
10 dagen geleden
Functieomschrijving

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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