Regulatory Affairs Specialist for Synthetic Small Molecules

15 hours ago

Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
About the Role

We are seeking a skilled Regulatory Affairs Specialist to join our team at Novo Nordisk A/S. As a key member of our RA CMC Synthetics & Cell Technologies department, you will play a crucial role in driving regulatory affairs strategies and submission activities related to synthetic small molecule projects.

Responsibilities
  • Provide strategic, tactical, and operational regulatory input to projects, leading activities for synthetic small molecule projects in late development.
  • Drive scientific and regulatory discussions across our portfolio, working closely with stakeholders across multiple functions in a global environment.
  • Apply regulatory intelligence and establish strategy for submission of clinical trial applications (CTAs) and marketing authorisations (MAAs).
  • Submission of regulatory files and responding to questions from health authorities.
  • Ensure preparation, review, and submission of pre-meeting packages for health authority meetings as well as conducting rehearsals and participating in the meetings.
  • Address process challenges by performing analyses and proposing new ways to support projects.
  • Identify phase appropriate regulatory risks and develop mitigation strategies.
  • Perform regulatory assessment of planned or implemented CMC changes based upon global regulatory guidelines.
Requirements
  • A Master and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health authority.
  • A minimum of 8+ years of experience with synthetic small molecules experience is preferred, as well as experience in the following areas:
    • In-depth knowledge of regulatory CMC requirements for clinical trial/investigational new drug applications.
    • In-depth knowledge of regulatory CMC requirements for marketing authorizations in the EU, US, and other major countries.
    • Extensive experience working with synthetic small molecules, including process design, analytical methodology, control strategy, process validation, and stability/shelf-life.
    • Understanding of phase appropriate drug development activities and milestones.
  • Excellent analytical skills, a systematic approach to identify root causes, and propose innovative ways to solve problems.
  • Ability to communicate complex scientific procedures with technical proficiency both orally and in writing.
  • Advanced level written and spoken English is a prerequisite.
What We Offer
  • An estimated annual salary of around €80,000 - €110,000 depending on experience, plus relocation assistance for candidates from abroad.
  • The opportunity to work in a dynamic company with a strong focus on innovation and patient-centric solutions.
  • A collaborative and empowering culture with talented colleagues who share your passion for making a difference in patients' lives.
About Us

We strive to be the best in the industry, delivering safe and innovative products to patients through strategic business partnering, proactive collaboration with health authorities, and efficient operations. Our organization is dynamic, and we focus on improving work processes both in relation to implementing new regulations and thinking 'out of the box'. We are committed to creating an inclusive culture that celebrates diversity and promotes equality of opportunity for all job applicants.

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