- 15 plus years pharmaceutical/biotechnology industry including extensive hands on global biologics strategy experience.
- Minimum of 10-15 years in RA.
- Comprehensive knowledge of applicable regulations.
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
- Comprehensive knowledge of GCPs and GLPs.
- Extensive experience in interfacing with regulatory authorities.
- Ability to lead and influence project teams, committees, etc. to attain group goals.
- Demonstrated leadership and communication skills.
- Ability to represent the department in project teams, committees and external meetings.
- Demonstrate strong organizational skills, including the ability to prioritize personal workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
- Well organized, detail oriented, effective written and oral communication skills.
- Ability to guide, train, supervise and prioritize workload of direct reports, as required.
- International regulatory experience preferred.
- Experience in the development of therapies for rare (orphan) and/or extremely rare (ultra-orphan) diseases desirable.
- BA/BS/University degree required, Life/Health Sciences preferred.
- Doctoral degree in the sciences, Pharmacy or Regulatory Science preferred
If you are interested in learning more about this position for our client, please send resume.
mtoohey AT contractstaffingrecruiters dot com
www dot contractstaffingrecruiters dot com