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Global Director Regulatory Affairs

Global Director Regulatory Affairs

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Global Director Regulatory Affairs

  • Location:

    Cambridge

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Arslan Sabir

  • Salary:

    Negotiable

  • Job type:

    Permanent - full time

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/04202_1674468330

  • Published:

    15 days ago

  • Startdate:

    ASAP

MSI Pharma have partnered with a global pharmaceutical organisation in the US who are seeking a Global Regulatory Director to spearhead transversal projects for the success of the business and company goals.

Responsibilities

  • You will ensure the development of robust regulatory strategies for multiple products and will be accountable for developing and maintaining global regulatory strategy documents.
  • You will be responsible for prioritizing projects and activities with the Global Regulatory Team for lifecycle management activities (i.e. renewals, variations, new registration expansions).
  • You will work with the Global Regulatory Team to develop and maintain the core dossier/Product Reference File.

Experience

  • Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA, Health Canada, PMDA, Chinese HA etc.)
  • Understanding of the Global (including CA, US, EU, WHO, China, Japan in particular) and pharmaceutical market place and familiarity with medical terminology.
  • Ability to work well within cross-functional teams and excellent transversal collaboration skills.
  • Strong sensitivity for a multicultural/multinational environment.

Qualifications

  • PhD, Pharm D or MSc in Biology or Life Sciences
  • Minimum of 5 years of experience of Global Regulatory Affairs experience
  • Experience of vaccines, microbiology, immunology, virology or bacteriology in development phase
  • Experience in mRNA is a bonus