Regulatory Affairs Director

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time
Job Title: Associate Director, Regulatory Affairs

As a key member of the MoonLakes team, you will play a crucial role in developing and delivering innovative global regulatory strategies for sonelokimab lead indication(s). Your expertise will be instrumental in ensuring compliance with regulatory requirements and facilitating the approval of all regulatory submissions.

Key Responsibilities:
  • Collaborate with cross-functional teams to develop and implement regulatory strategies that align with business objectives.
  • Support interactions with global regulatory agencies to facilitate approval of regulatory submissions.
  • Coordinate the preparation, review, and submission of regulatory dossiers to support clinical studies, marketing applications, and scientific advice.
  • Provide expert advice to internal teams on regulatory issues and ensure up-to-date knowledge of guidelines and regulatory trends.
  • Lead the development of processes, SOPs, and other controlled documents, including for Regulatory Affairs activities.
Requirements:
  • Minimum of first degree in life sciences (or equivalent); advanced degree (e.g. PhD or Masters) preferred.
  • Minimum of 7 years of experience within regulatory affairs in pharmaceutical industry/Biotech industry, ideally in a relevant disease area.
  • Experience in clinical development, nonclinical development, or working globally with FDA and/or EMA and national health authorities.
Skills and Competencies:
  • Ability to create and implement innovative regulatory strategies.
  • Strong understanding of the drug development lifecycle and regulatory requirements.
  • Adaptable with the ability to generate creative solutions and adapt to changing priorities and deadlines.
  • Highly collaborative with strong relationship building skills and a high level of integrity.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. If you are interested in this opportunity, please visit our website for more information and to apply.

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