RIMS, xEVMPD, IDMP Lead

The role is responsible for the Regulatory IT Systems e.g. RIM. Ensuring system implementation maintenance and updates are managed and communicated in a timely and effective manner.

Key Responsibilities (Including but not limited to the following):

• Act as the Business System Owner for Veeva RIM and as such ensure that the system and its operation is in compliance and fit for intended use and purpose.
• Participate in the impact assessment and testing of all releases.
• Ensure that applicable SOPs WIs and user guides are updated.
• Ensure that trainings are available and given to Veeva RIM end users.
• Ensure that core data including xEVMPD and IDMP data is kept up to date.
• Coordinate the updates of our existing registered medicinal products and ensure registration of new approved products.
• Keep relevant stakeholders informed on the latest updates of Veeva RIM xEVMPD and IDMP.
• Ensure that the eCTD templates library is maintained and kept up to date.

Qualifications :

About you:

All Sobi employees need to demonstrate behaviors in line with Sobis core values: Care Ambition Urgency Ownership and Partnership.

• A University Degree in Life Sciences is required with 5 years of industry experience within Regulatory Affairs in business operations
• Experience of Regulatory Business Operations and project management
• Demonstrated ability of working with cross-functional teams in a complex changing environment
• Project communication and stakeholder management skills
• Proven to be able to be analytical connect the dots and propose a strategy to address challenges and business needs
• Results driven and team-oriented attitude with the ability to influence outcomes. 
• Excellent organizational and time management skills to effectively manage multiple ongoing projects simultaneously
• Proven ability to innovate especially with analysing & solving problems with minimal supervision and exceptionally keen skills forattention to detail. 
• Proven success in simultaneously handling strategic and transactional responsibilities especially in a small-team environment
• Good use of MS office suite and Veeva RIM
• Fluent in English^. Knowledge of any other languages would be an asset.
• Global experience desirable
• Travel occasionally (domestic and international).

Additional Information :

Why Join Us

Here at Sobi our mission and culture get us excited to come to work every day but here are a few more reasons to join our team:

• Competitive compensation for your work
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

We are a global company with over 1700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

Remote Work :

No

Employment Type :

Full-time