Global Regulatory Compliance Lead

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 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 followup.

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 crossfunctional SMEs.
• Act as Global Process Owner for assigned procedures.
• Manage GRA Business Contingency Plan responsibilities
• Lead preparations and 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 crossfunctional teams.

Skills/Knowledge/Languages

• Strong coordination skills.
• Proficiency in working with the MSOffice 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 crossfunctional collaboration.

Personal Attributes

• Results driven and teamoriented attitude.
• Excellent organizational and time management skills.
• Handson approach and flexibility to succeed in a smallteam environment within a growing organization.

Additional Information :

All Sobi employees need to demonstrate behaviors in line with Sobis 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 1700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday 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 firsthand 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 groundbreaking 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.

An Equal Opportunity Employer

Sobi 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

Remote Work :

Yes

Employment Type :

Fulltime