Senior Regulatory Consultant, FDA, INDs and CTAs.
This role is to provide senior level, experienced regulatory leadership to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures and best practices, including compliance.
Duties will include:
- For assigned projects, acting as an accountable agent on behalf of the company to the U.S. Food and Drug Administration (FDA) and affiliates as applicable to work with ex-US Health Authorities
- Providing experienced stakeholder management, interfacing directly with internal stakeholders of various levels.
The ideal candidate will have:
- Clinical regulatory role[s] in industry.
- Competence in teamwork (cross functional)/collaboration, achieving results, regulatory knowledge, operational excellence.
- Competence in strategic agility, communication (stakeholder management), leadership, pharma drug development, organizational and business knowledge.
- Level of direct therapeutic area experience.
- Experience in regulatory affairs (US, EU, ROW); experienced in submission requirements and HA interactions.
- Knowledge of GxP, ICH, and other regulatory guidelines; experience in providing regulatory assessments and guidance including considering precedence and relevant HA guidance through many project-level activities.
- Knowledge and deep experience of the drug development process from IND/CTA opening through final product approval, and how other functions contribute to a regulatory submission (IND/CTA/IMPD, NDA/BLA/ANDA/MAA, etc.).
- Strong regulatory program management, leadership, teamwork, and communication skills.
submit your CV
- Contract Type:
1099 / W2
US based, remote working
12 months +
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