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.
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- Contract Type:
US based, remote working
12 months +
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