Employer Industry: Pharmaceuticals

Why consider this job opportunity:
- Salary up to $X (specific amount not provided)
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
- Opportunity to participate in short-term and long-term incentive programs
- Hybrid work schedule with flexibility for remote work within the United States
- Chance to work on impactful projects in oncology, influencing product development and regulatory strategies

What to Expect (Job Responsibilities):
- Develop and implement regulatory strategic and tactical planning for products in the US and Canada
- Manage interactions with Health Authorities, including the FDA, for key projects
- Advise internal teams on regulatory issues and support communication with Health Authorities
- Coordinate and oversee the preparation of regulatory submissions in compliance with US and Canada regulations
- Mentor and develop staff members while leading regulatory initiatives within the organization

What is Required (Qualifications):
- Bachelor’s Degree in pharmacy, biology, pharmacology, or related life sciences
- Minimum of 8 years of Regulatory, R&D, or industry-related experience
- Extensive experience interfacing with government agencies and Health Authority personnel
- Strong communication skills, both written and oral, across regulatory and organizational levels
- Proven ability to implement successful US and Canada regulatory strategies

How to Stand Out (Preferred Qualifications):
- Relevant advanced degree and certification in regulatory affairs
- 5 years of experience in pharmaceutical regulatory affairs
- Experience working in a complex and matrix environment
- Demonstrated success in negotiation and strategic thinking
- Global regulatory experience

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