Regulatory Lead

Medical · Oslo/Copenhagen, Norway/Denmark
Department Medical
Employment Type Full-Time

Our team is now looking for a Regulatory Lead who will serve in the project team for a Nykode project in early clinical development. Here, the Regulatory Lead will be responsible for global regulatory strategies and provide operational and strategic regulatory input as needed. The person may be based in either Oslo/Copenhagen, Denmark.

The individual will lead, initiate and drive the many regulatory activities, including clinical trial applications and agency interactions and act as an active member of relevant clinical teams. You will ensure high quality documentation in regulatory submissions such as clinical trial applications, IND submissions, and meeting briefing packages and effectively manage associated timelines. Furthermore, you will lead the regulatory subteam and will play an active role in the continuous development of the regulatory function within Nykode.

The responsibilities of this position include:

  • Developing and executing sound and robust global regulatory strategies, plans, and activities for Nykode’s products
  • Actively participating in project teams and relevant trial teams
  • Leading and coordinating regulatory activities with Regulatory CMC, documentation specialists, and relevant other internal and external parties
  • Providing input and support to Quality, Preclinical, and Clinical activities and plans
  • Ensuring compilation and filing of relevant regulatory applications, including orphan designation applications and paediatric plans and manage associated timelines
  • Collaborating with the Clinical Operations team and clinical CROs on compilation of clinical trial applications
  • Ensuring timely follow-up on Health Authority requests and commitments
  • Leading the creation of briefing packages and preparing the team for participation in Health Authority meetings as needed
  • Handling contact to regulatory authorities
  • Staying up-to-date with and communicating relevant regulatory guidances and regulations
  • Ensuring that relevant SOPs are in compliance with regulatory requirements and standards
  • Managing regulatory vendors, including vendor selection, vendor communication and supervision, and reviewing and approving invoices

The Regulatory Lead will report to Head of Regulatory Affairs.

Key qualifications

  • MSc in a scientific discipline or health-related field
  • At least 5 years of Regulatory Affairs experience within global pharmaceutical development
  • Experience with the US and EU regulatory environment, including Agency interactions is preferred
  • Experience with ATMP or biological product development
  • Experience within oncology an advantage
  • Excellent English fluency is required, both verbal and written 
  • Skilled user of various IT systems

Location: Oslo Science park/Forskningsparken, Norway/Copenhagen, Denmark.

Appplications will be reviewed on a rolling basis. Please reach out to our recruiter Peter Christensen for any questions, He can also be reached on +45 4095 0420.

Who are we looking for?

When hiring new employees, we also look for the individuals who are inspired by Nykode's entrepreneurial spirit and whom we think would be a good fit with our collaborative and inclusive company culture. We believe that you are driven by an eagerness to learn, you are proactive and not afraid of facing new challenges. You are ambitious, felxible, and have an appetite for working in a energetic start-up company to “get things done”.

For this role, it is essential that you are an experienced user of Microsoft 365 and electronic document management systems. You thrive by working both independently as well as in teams, as this role will be closely interact with regulatory subteams. Strong analytical and organisational skills as well as being able to notice the smallest details in documentation completion.

Why join our Nykode team?

At Nykode, we offer a fun and dynamic international working environment. The people are at the heart of our organization, which is why we always keep striving to offer a workplace where we cheer each other on and find motivation. Your skills and competencies are unique and to ensure continued development our aspiration is to provide you with good opportunities for personal growth. We care about each other.

Thank You

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  • Location
    Oslo/Copenhagen, Norway/Denmark
  • Department
  • Employment Type