inVentiv Health 0000101031-NA Regulatory Leader Vaccines in New Jersey
- Detailed Job Description: Will be the primary contact for the US FDA for Vaccine products, works closely with Global Regulatory Leader to execute the North America regulatory strategy as defined and agreed by the R&D team. Approves submissions before dispatching to FDA.
-Responsibilities will include: maintenance activities of open INDs, co-ordination of pre-IND interactions, timely safety events reporting, …
Required Technical Competencies & Knowledge:
Knowledge of local laws, regulations and guidances related to full drug life cycle.
Understanding of how laws, regulations and guidances apply to specific projects. Ability to interpret them and understand them in the context of the scientific and commercial environment.
Broad understanding and experience of drug development and/or marketing products.
Ability to stay abreast of regulatory developments.
Understanding of the scientific and medical principles applicable to the therapeutic area and specific products.
Broad understanding of lifecycle management
HA and Operating Company Interactions
Knowledge of FDA & how agency operates.
Knowledge of commercial business needs.
Understanding of scientific data (clinical and non-clinical – Vaccine experience preferred) and ability to translate it into regulatory argument.
Knowledge of what questions to ask of HAs and when in the life cycle is the right time to ask them.
Detailed knowledge of laws, regulations, and guidance as they apply to submissions.
Understanding of documentation requirements.
Ability to analyze documents to determine whether they meet regulatory requirements, and are consistent with the regulatory strategy.
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inVentiv Health, Inc. is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace.