Regulatory Affairs Director

Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. We also take pride in having a great working climate!

Our vision is to bring unique life-improving therapies to patients with rare diseases. Egetis Therapeutics currently has two drug candidates in late-stage clinical development, and we are continuously seeking opportunities to grow our pipeline. We are now on an exciting journey to establish our own teams for product launches in Europe and North America.

We are committed, courageous, and collaborative people. Become a part of our inspiring environment. We care for the rare!

We have an Office downtown Stockholm where you are welcome to join us for work. However, we are flexible if you prefer to work from home anywhere in the world.

The Regulatory Affairs Director is responsible for strategic and operational regulatory contributions to

• Planning and development of global regulatory strategies, delivery of regulatory activities and regulatory project management - from regulatory path planning to regulatory submission and post marketing regulatory change assessment.
• Together with the Global Head Regulatory Affairs, responsible for planning and managing regulatory submissions and interactions with Health Authorities including scientific advisory meetings.
• Responsible for delivery of regulatory activities and regulatory project management, including e.g

• • Preparation, compilation, and review of regulatory documentation to ensure consistency with established regulatory policies.
• • Regulatory applications (e.g. marketing authorization and extension applications, clinical trial applications, renewals, variations and supplements)
• • Preparing and submitting responses to requests from regulatory agencies
• • Regulatory yearly updates (e.g. SME designation, annual reports for orphan drugs etc)
• • Ensures proper internal regulatory documentation and document management
• • Ensuring compliance with regulatory requirements and regulations
• • Identifies the need for new regulatory policies, processes, and SOPs
• • Manage all aspects of labelling and packaging activities to ensure compliant with the regulations and ready for product launch
• • Regulatory support to potential managed access programs
• • Product maintenance and life-cycle management

Your Background

Education

• Scientific background: MSc, PhD, MBA or equivalent

Experience

• Experience in internal as well as external, collaborations.
• Broad experience in Regulatory Affairs during drug development (minimum 7 years)

Competencies

• Manage Complexity: Making sense of complex, high quantity, and sometimes contradictory information to effectively solve problems.
• Action Oriented: Taking on new opportunities and tough challenges with a sense of urgency, high energy and enthusiasm.
• Plan and Align: Planning and prioritizing work to meet commitments aligned with organizational goals.
• Ensure Accountability: Holding self and others accountable to meet commitments.
• Collaborate: Building partnerships and working collaboratively with others to meet shared objectives.
• Manage Ambiguity: Operating effectively, even when things are not certain or the way forward is not clear.

Values

Naturally you share our values:

• Courage - We challenge the status quo for the benefit of the patient
• Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results
• Collaboration – Through trust, we work seamlessly across functions and with external partners