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Director Regulatory Affairs

Sweden, Lund Employment contract · Job Posted June 10, 2026
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Job Description

As Director Regulatory Affairs you will report to the Chief Regulatory Affairs Officer, and will be a part of our Regulatory Affairs and Clinical Reporting department, currently a team of five regulatory and three medical writing colleagues. You will be playing a pivotal role in developing and executing global regulatory strategies supporting drug development programs, as well as hands-on work leading regulatory submissions and approvals.

Job Responsibility

  • Lead and contribute to regulatory strategies for assigned projects that expedite development, maximize the probability of success and mitigate risks
  • Play a hands-on role in planning, preparing and coordinating regulatory documents for submission to global health authorities as part of regulatory filings, such as CTAs/INDs, amendments, annual updates, paediatric investigation plans, orphan drug applications, fast track applications, responses to health authority information requests and BLAs/MAAs
  • Managing and leading the planning and preparation of meeting requests and meeting packages for health authority interactions for assigned projects
  • Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards
  • Provide regulatory leadership and guidance to cross-functional project teams and lead the development, strategy and execution of regulatory submission documents while working collaboratively with the project team including a variety of personnel and staff
  • Liase with internal QA and CMC teams ensuring regulatory requirements are consistently met across QA and manufacturing functions.

Requirements

  • Education in the natural sciences space with an MSc degree in Pharmacy, Chemistry or similar
  • Ideally 10+ years’ experience in industry and 7+ years in Regulatory Affairs
  • Experience in preparing regulatory strategies/regulatory development plans, highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
  • Experience with clinical trial submissions and approvals
  • Previous experience in a senior regulatory role, including health authority interactions, e.g. FDA and EMA meetings is required, and experience with BLA/MAA dossier preparation and submissions is desirable
  • In-depth understanding of regulations and guidelines governing all phases of drug development
  • Highly resourceful team-player, with the ability to be also extremely effective independently
  • Strategic mindset, innovative yet pragmatic/solution-oriented thinking, at the same time keen to also work in an operational role with attention to detail
  • Strong written and oral communication skills
  • comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities.
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