Global Regulatory Compliance Lead

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

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

Job Description

The Global Regulatory Compliance Lead is responsible for leading assigned Regulatory Compliance activities, including but not limited to activities related to the procedural document creation and updates, audit and inspection execution and preparation and regulatory risk management. The role will also support the Global Regulatory Affairs department with various operational quality and compliance activities, as well as training assignments and follow-up.

This position will be within Global Regulatory Affairs (GRA) and will report to the Head of Compliance, Business Operations.

This is a remote position - candidates located in Sweden are preferred.

Key Responsibilities:

• Lead assigned Regulatory Compliance work and improvement activities
• Act as Quality Training Contributor (QTC) for the department: manage GRA training curricula and Learner Roles, assignment of training to GRA, follow up on training compliance and 1st line support in Veeva Quality for GRA.
• Manage parts of onboarding- and exit activities for employees and consultants in relation to training.
• Lead procedural documents creation and updates, involving regulatory and cross-functional SMEs.
• Act as Global Process Owner for assigned procedures.
• Manage GRA Business Contingency Plan responsibilities
• Lead preparations and execution of audit and inspection activities as relevant for regulatory.
• Follow up on change control, deviations and continuous improvement activities.
• PSMF responsible within Global Regulatory Affairs.
• Escalate any compliance and/or quality risk internally
• Support regulatory compliance activities in acquisitions and integrations.

Qualifications

Education/Learning Experience/Work Experience

• Experience from Life Science/pharmaceutical industry.
• Experience from quality-, regulatory- or pharmacovigilance related work.
• Experience from regulatory compliance and process management is a plus.
• Experience working in a global environment.
• Strong track record of leading projects and collaborating effectively in cross-functional teams.

Skills/Knowledge/Languages

• Strong coordination skills.
• Proficiency in working with the MS-Office Suite.
• Fluency in English, additional language skills are a plus.
• Ability to think holistically, communicate effectively, and drive initiatives.
• Strong attention to detail and focus on quality.
• Comfortable working across geographies and in a culturally diverse organization with extensive cross-functional collaboration.

Personal Attributes

• Results driven and team-oriented attitude.
• Excellent organizational and time management skills.
• Hands-on approach and flexibility to succeed in a small-team environment within a growing organization.

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,700 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, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into yo