Head of Regulatory Business Operations

2 weeks ago

Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
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 role leads and manages the Regulatory Business Operations team, is responsible for managing the GRA budget, Regulatory Systems and GRA outsourcing vendor.

Oversees the implementation and maintenance of the Veeva RIMS system (post Go-Live), Veeva PromoMats and provides strategic direction to the Regulatory Business Operations team and the projects they have oversight of.

Will be the primary contact for the outsourcing vendor GRA role and RDMA finance lead and ensure the successful implementation of a fit for purpose Vendor Management Tools and Processes and manage the budget.

Candidates Located In Sweden Are Preferred

Key Responsibilities/Scope of the Job

Including, But Not Limited To The Following

  • Provides leadership and line management to direct reports including training, performance management, professional development and coaching.
  • Makes decisions on administrative and operational matters and ensures the Regulatory Business Operations team effectively achieves its objectives.
  • Is responsible for the Regulatory systems including Veeva RIMs, publishing tools and related business processes.
  • Is responsible for the Veeva PromoMats Health Check and developing the strategic road map in collaboration with ISIT, Commercial and Medical.
  • Manages the GRA budget and keeps the RDMA finance person updated on a regular basis.
  • Supports and develops in collaboration with the Vendor Manager the implementation of the Vendor Management processes and tools, supports development and maintenance of Quality Agreements (QAs) and different service levels agreements (as applicable).
  • Drives communication and training to ensure business operations team and outsourcing vendor adhere to the operating model and efficient execution.
  • Actively contributes to the development of a robust governance model and ensures that activities and documentation are agreed with relevant stakeholders are reviewed and updated on a regular basis.
  • Ensures vendor oversight with the alliance lead for GRA including but not limited to building, facilitating, and maintaining a long-lasting relationship between Sobi and the chosen GRA outsourcing vendor.
  • Actively contributes to developing or harmonising the governance structure, with the Vendor Alliance Manager.
  • Liaises with internal GRA teams, subject matter experts and stakeholders, the outsourcing vendor organisation, and procurement to support Service Agreement (SA) contract negotiations
  • Develops strategic partnership Key Performance/Quality indicators (KPIs/KQIs) and assesses needs for process improvement
  • Contributes to the development and maintenance of Regulatory Affairs working practices & procedures.
  • Additional duties may be assigned, as needed.

Qualifications

Education/Learning Experience/Work Experience
  • A University Degree in Life Sciences is required with 10 years of industry experience of which at least 8 years of experience within Regulatory Affairs in a business operations and vendor alliance management role and at least 5 years of formal people management.
  • Extensive experience of regulatory operations and project management
  • Experience of leading and managing a team of subject matter experts
  • First-hand experience of working directly with service providers, and demonstrated ability of managing and working with cross-functional teams in a complex, changing environment
  • Strong project and stakeholder management skills
  • Excellent oral and written communication skills and diplomacy to convey information and influence others with a strong customer focus
  • Experience in change management, financial analysis, and negotiation
  • Good use of MS office suite
  • Fluent in English
  • Global experience desirable.

Skills/Knowledge/Languages
  • Working knowledge of Veeva RIMS platform and knowledge of regulatory systems
  • Working knowledge of Veeva PromoMats
  • Above-average proficiency with basic technology tools (e.g. MS-Office, etc.).
  • Demonstrate excellent communication skills (oral/written/listening) in English. Knowledge of any other languages would be an asset.
  • Proven to be able to be analytical, connect the dots and propose a strategy to address challenges and business needs

Personal Attributes
  • 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.
  • Ability to travel occasionally (domestic and international)

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 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 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 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
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