Principle Regulatory Consultant

Principle Regulatory Consultant

The Role

1. Lead projects, ensuring team alignment with client expectations, and deliver high-quality results.
2. Apply best practices in project management, including conducting workshops, gathering client requirements, selecting vendors, and coordinating data migrations.
3. Act as an intermediary between business needs and software vendors.
4. Optimize business processes to meet both internal standards and external regulatory requirements.
5. Champion the organization’s values and promote effective working methods.
6. Cultivate a collaborative, knowledge-sharing team environment to drive continuous improvement.
7. Join a forward-thinking community, contributing to a vibrant, dynamic team.

Your Background

1. With 5 to 8+ years in the pharmaceutical industry, you bring deep experience in Regulatory Operations and Information Management.
2. Skilled in steering digital transformation within Life Sciences, you enable data-driven regulatory submissions and process automation.
3. A comprehensive understanding of regulatory processes and data allows you to collaborate effectively across the pharmaceutical value chain.
4. Experienced in data management, including Data Governance and Master Data Management.
5. Knowledgeable in xEVMPD and IDMP, with familiarity in guidelines like the EU IDMP Implementation Guide.
6. Proven experience in implementing and operating RIM systems, and expertise in crafting data migration strategies.
7. Your ability to bridge business and technology enables effective translation across teams.
8. A background in ontologies and semantic data modeling is an asset.
9. Strong analytical skills, attention to detail, and an ability to see the broader perspective.
10. Team-oriented and communicative, you thrive in collaborative environments.

Why Join Us?

1. We provide pathways for professional growth, with personalized development plans and mentoring from experienced colleagues in a fast-paced and expanding company.
2. Engaging projects and unique challenges in an evolving market with leading global clients.
3. Be part of a talented international team with flexibility in work hours, remote options, and cutting-edge technology for virtual collaboration.
4. Competitive, performance-based compensation, with a commitment to transparency, individuality, and frequent team-building events.
5. We promote a healthy work-life balance, ensuring a rewarding and enjoyable work environment.

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