Director/Senior Associate Director, US Product Group Oncology Regulatory Affairs (Hybrid)
- Brampton, ON
- Hybrid
- Posted Aug 21, 2026
- 1 position
US$170,000–US$350,000 / year
- Employment type
- Full-time
- Experience level
- Lead · 10+ years
- Minimum education
- Bachelor’s degree
- Posting language
- English
- Working hours
- 40 hours per week
- Office presence
- 3 days per week
This job has expired
This position at Boehringer Ingelheim is no longer accepting applications. The original posting remains below for reference.
Expired Oct 7, 2026
Original job posting
The incumbent provides expert US regulatory leadership for development projects and marketed products, acting as the primary liaison with the FDA. They are responsible for developing comprehensive regulatory strategies, ensuring compliance, and driving alignment across cross-functional teams.
Job details
The incumbent provides expert US regulatory leadership for development projects and marketed products, acting as the primary liaison with the FDA. They are responsible for developing comprehensive regulatory strategies, ensuring compliance, and driving alignment across cross-functional teams. Candidates must possess a Bachelor's degree in life sciences, pharmacy, or chemistry with extensive drug development experience, or a postgraduate degree with significant regulatory experience. A minimum of 8 to 10 years of experience in the regulated pharmaceutical industry is required, along with advanced leadership and strategic negotiation skills.
What you’ll do
The incumbent provides expert US regulatory leadership for development projects and marketed products, acting as the primary liaison with the FDA. They are responsible for developing comprehensive regulatory strategies, ensuring compliance, and driving alignment across cross-functional teams.
Requirements
Candidates must possess a Bachelor's degree in life sciences, pharmacy, or chemistry with extensive drug development experience, or a postgraduate degree with significant regulatory experience. A minimum of 8 to 10 years of experience in the regulated pharmaceutical industry is required, along with advanced leadership and strategic negotiation skills.
Benefits
- Competitive compensation
- Performance based bonus
- Work-life balance support
- Networking opportunities
Listed skills
- Regulatory Compliance · Preferred
- Negotiation · Preferred
- Critical Thinking · Preferred
- Project management · Preferred
- Conflict Resolution · Preferred
- Stakeholder Management · Preferred
- Labeling · Preferred
Other relevant skills
Identified from the job description. Confirm important requirements above.
- Regulatory affairs
- FDA liaison
- Strategic planning
- Drug development
- Regulatory compliance
- Risk assessment
- Cross-functional leadership
- Project management
- Labeling
- Pharmacovigilance
- Negotiation
- Conflict resolution
- Critical thinking
- Stakeholder management
- Regulatory strategy
Job areas
- Healthcare
- Management & Leadership
- Science & Research
- Legal
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