Senior, Principal Consultant – Regulatory

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MAIN5

WebsiteLinkedInAll Job Openings

51 - 200 employees

At MAIN5, we redefine consulting with a dynamic and forward-thinking approach, positioning ourselves as leaders in the ever-evolving landscape of the Life Sciences Industry. With over 60 dedicated professionals, we are committed to driving innovation and digital transformation for our clients. Our Core Values: Innovation, Expertise, and Excellence Innovation: In a world shaped by rapid advancements, MAIN5 stands at the forefront of industry trends. We embrace innovation as a guiding principle, ensuring our clients stay ahead in the competitive life science sector. Our commitment to cutting-edge technologies is unwavering, making us your strategic partner in navigating the digital age. Expertise: With a team of seasoned professionals, MAIN5 brings unparalleled expertise to the table. Our consultants are adept in Regulatory Affairs, Quality, Safety, Clinical, and other critical areas along the R&D value chain. We provide tailored solutions that align with your unique challenges, leveraging our deep industry knowledge to drive success. Excellence: At MAIN5, excellence is not just a goal; it's our standard. We pride ourselves on delivering tangible and sustainable results for our clients. Our track record showcasing a history of successful projects in Change Management, Business Process Management, System implementations, eLearning, Quality & Compliance that have empowered organizations to thrive in the face of complexity.

📋 Description

• Lead regulatory projects that matter: RIM system implementations with a strong focus on Veeva Vault RIM, IDMP readiness, regulatory data management and data quality initiatives for top pharma and life sciences companies. • Own your results: As Senior Consultant, you independently run sub-projects and small to mid-sized engagements. As Principal Consultant, you take charge of bigger projects and program segments including timelines, budget, risks and KPIs. • Be the person clients trust: You're the main contact at project level, from regulatory operations teams up to senior stakeholders. You run workshops, manage expectations and turn client needs into solutions that work in practice. • Help us grow: You contribute to proposals and pitches and spot opportunities where we can create more value for our clients. As Principal Consultant, you gradually take on more ownership for client relationships and new business with our full support. • Share what you know: You mentor consultants, contribute to our Communities of Practice and help shape our regulatory service offering. • Show up for the industry: You represent MAIN5 at conferences, client events and industry forums.

🎯 Requirements

• A university degree in life sciences, pharmacy, computer science or a related field or a comparable background with relevant experience. • Solid experience in Regulatory Affairs: You’ve spent years in the pharmaceutical / life sciences industry or consulting, with a clear focus on regulatory processes, data and systems. • Hands-on RIM expertise — Veeva Vault RIM in particular: You've worked with regulatory information management systems – ideally Veeva Vault RIM – in implementation, migration or optimization projects, and you know your way around Health Authority requirements such as IDMP. • A real consulting toolbox: Structured problem solving, project management, workshop facilitation and stakeholder management are things you do, not just buzzwords on your CV. • Client presence: You present complex topics clearly, handle demanding stakeholders with confidence and keep your cool when priorities shift. • Fluent English; German is a plus, not a must.

🏖️ Benefits

• Remote-first, for real: work from where you work best • Family-friendly by design: flexible hours that fit around your life, not the other way around. • Adult working culture: we hire experienced people and treat them that way. • People first: open communication on equal footing, a team that has your back, and leaders who listen. • Fair package: attractive compensation with bonus opportunities and modern equipment for wherever you work.