Job Type
Permanent
Emp Type
Full Time
Functional Expertise
Regulatory Affairs
Salary Type
Annual
Job Description
Principle Regulatory Consultant
The Role
- Lead projects, ensuring team alignment with client expectations, and deliver high-quality results.
- Apply best practices in project management, including conducting workshops, gathering client requirements, selecting vendors, and coordinating data migrations.
- Act as an intermediary between business needs and software vendors.
- Optimize business processes to meet both internal standards and external regulatory requirements.
- Champion the organization's values and promote effective working methods.
- Cultivate a collaborative, knowledge-sharing team environment to drive continuous improvement.
- Join a forward-thinking community, contributing to a vibrant, dynamic team.
Your Background
- With 5 to 8+ years in the pharmaceutical industry, you bring deep experience in Regulatory Operations and Information Management.
- Skilled in steering digital transformation within Life Sciences, you enable data-driven regulatory submissions and process automation.
- A comprehensive understanding of regulatory processes and data allows you to collaborate effectively across the pharmaceutical value chain.
- Experienced in data management, including Data Governance and Master Data Management.
- Knowledgeable in xEVMPD and IDMP, with familiarity in guidelines like the EU IDMP Implementation Guide.
- Proven experience in implementing and operating RIM systems, and expertise in crafting data migration strategies.
- Your ability to bridge business and technology enables effective translation across teams.
- A background in ontologies and semantic data modeling is an asset.
- Strong analytical skills, attention to detail, and an ability to see the broader perspective.
- Team-oriented and communicative, you thrive in collaborative environments.
Why Join Us?
- We provide pathways for professional growth, with personalized development plans and mentoring from experienced colleagues in a fast-paced and expanding company.
- Engaging projects and unique challenges in an evolving market with leading global clients.
- Be part of a talented international team with flexibility in work hours, remote options, and cutting-edge technology for virtual collaboration.
- Competitive, performance-based compensation, with a commitment to transparency, individuality, and frequent team-building events.
- We promote a healthy work-life balance, ensuring a rewarding and enjoyable work environment.
#LI-OG1
