Director, Global RA Strategy REF: 790
G&L Scientific is the preferred supplier of regulatory contract resource to a global Biopharmaceutical company, headquartered in NYC.
We have a large team of skilled professionals working across multiple business units and they have now asked us to provide them with additional talent for an upcoming project.
We are looking for experienced, senior, regulatory professionals ideally with a strong background in oncology products to work on NDA/IND projects with the FDA.
The role will include:
- Responsibility for developing and implementing the global regulatory strategy to support the development and delivery of drug products
- Providing regulatory support and guidance to Regulatory leads, development teams, commercial and diagnostic teams on the regulatory strategy and execution of the integrated drug development plan
- Ensuring global regulatory plans support an approach, including health authority engagement plans and mitigation strategies
- Supporting the preparation of health authority documents and governance presentations containing precision medicine plans
- Ensuring consistent positions are presented in responses to global health authority queries
- Proposing innovative approaches to resolve complex regulatory issues and increase speed to patients
- Providing 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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