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Regulatory Manager – Oncology REF: 589

Regulatory Affairs lead role in Oncology and CV for marketed products that also have ongoing development programs.

  • Responsibility for developing and implementing the global regulatory strategy to support the development and delivery of drug products to enhance the value of our pharmaceutical products across therapeutic areas.
  • Provide regulatory support and guidance to Global Regulatory Leads (GRTLs), development teams, commercial and/or project drug/diagnostic subteams on the regulatory strategy and execution of the integrated drug development plan.
  • Ensure global regulatory plans support an approach (ie integrated drug/ regulatory and submission plans), including HA engagement plans and mitigation strategies.
  • Support the preparation of health authority documents and governance presentations containing precision medicine plans.
  • Ensure consistent positions are presented in responses to global health authority (HA) queries.
  • Propose innovative approaches to resolve complex regulatory issues and increase speed to patients.
  • Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products.

REF: 589

  • Contract Type:

    Contract opportunity

  • Location:

    US based, remote working

  • Duration:

    12 months +

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