Offer summary
Qualifications:
BS degree required; advanced degree preferred, 7+ years of pharmaceutical industry experience for Sr. Manager; 10+ years for Associate Director, Experience with regulatory authorities required, Strong written and verbal communication skills, Knowledge of drug development process and regulations.
Key responsabilities:
- Lead regulatory strategy for development programs
- Mentor staff on regulatory plans and strategies
- Author key regulatory submissions and briefs
- Interact with regulatory agencies and prepare for interactions
- Manage communication regarding project status and issues