Boehringer Ingelheim is looking to solve the problem of regulatory compliance and strategy in the pharmaceutical industry, specifically in the areas of cardiology, diabetes, immunology, oncology, and respiratory, by developing competencies in regulatory affairs and policy
Requirements
- Knowledge of US regulations and guidelines
- Understanding of regulatory trends and developments
- Experience with regulatory compliance and strategy
- Ability to analyze and interpret regulatory intelligence
- Familiarity with regulatory intelligence data sources and service providers
- Experience with cross-functional teams
- Knowledge of global regulatory policy issues
Responsibilities
- Develop, compile, and integrate regulatory intelligence from health authorities, professional groups, publicly available information and BI
- Appropriately communicate regulatory intelligence within the organization
- Provide analysis, advice, and guidance on US regulatory strategies to promote expedited product development and approval
- Research information on regulatory policies and departmental policies within and external to RA
- Research and implement processes to improve regulatory intelligence and collaboration
- Develop expertise on projects from the regulatory intelligence and policy perspective
- Collaborate with BI Government Affairs to ensure knowledge sharing of overlapping intelligence topics
Other
- PhD degree in Pharmacy or related field
- Ability to work in a team environment
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced environment
- Strong analytical and problem-solving skills