Head of Regulatory Affairs – Cell Therapy Immunology
| Company | AstraZeneca |
|---|---|
| Location | Boston, MA, USA |
| Salary | $266596.8 – $399895.2 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PharmD, PhD, MD |
| Experience Level | Expert or higher |
Requirements
- Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
- More than 10 years drug development experience
- Broad experience of the therapeutic area, with specific cell therapy immunology regulatory sciences expertise and immune-mediated diseases.
- Experience in global regulatory strategy and submissions that have progressed through to registration
- Must have significant experience in leading major Health Authority interactions
- Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
- Experience in managing people in a matrixed organizational structure
Responsibilities
- Provide oversight, partner with, and mentor RADs and SrRADs to produce strategies for a product/group of products in the Immunology Cell Therapy TA that are consistent with the disease area and portfolio strategy.
- Leads discussions in both internal and external forums, providing expertise in regulatory knowledge of disease area.
- Influences and drives regulatory strategies and recommendations at all stages of development, in early and late development, and for established brands on regulatory components of development specific to cell and gene therapies as well as other tools such as novel endpoints/biomarkers, novel study designs, and digital applications.
- Effectively represent the Regulatory function in senior level interactions at internal governance technical review committees e.g. Development Review Committee (DRC/eDRC), Early Development Review Board, Global Medical Affairs (GMA) Review Committees.
- Works in collaboration with regional policy and intelligence groups to critically analyse the assessment of emerging science, data and changes in the regulatory environment.
- Defines and drives disease area global regulatory policies and priorities within the TA.
Preferred Qualifications
- Advanced degree in a scientific field (e.g. MSc, PhD, PharmD, MD)