Global Regulatory Compliance Lead

Job title:

Global Regulatory Compliance Lead

Company

Sobi

Job description

Company DescriptionStatistics 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 DescriptionThe 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.

QualificationsEducation/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 InformationAll 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 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 CultureAt 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 can’t 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.An Equal Opportunity EmployerSobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to .

Expected salary

Location

Stockholm

Job date

Sat, 12 Apr 2025 05:45:20 GMT

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