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Global Regulatory Strategy Consultant – oncology REF 1076

Responsibilities:

  • Global Regulatory Strategy Lead has leadership 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, 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.

Qualifications:

  • Solid scientific background, Ph.D., M.D., PharmD, MS, or BS with significant experience in regulatory affairs related development (e.g. > 10 years).
  • Understanding of scientific content and complexities and good knowledge of Oncology drug development is desired.
  • Experience working with external partners.
  • Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
  • Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.
  • Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.
  • Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
  • Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
  • Experience utilizing leadership techniques to drive a team through the stages of team development.
  • Prior experience with SRDs, IDEs, and PMAs is highly desired.
  • Contract Type:

    1099 / W2

  • Location:

    US based, 50% onsite (CA, NJ, MA, FL, NY)

  • Duration:

    12 months +

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