Regulatory Affairs Director
4 weeks ago
Job Summary
The Director, Regulatory Strategy is responsible for leading the development and execution of regulatory strategies for assigned brand programs. This includes providing regulatory pathways for product development, interacting with regulatory agencies, and communicating with stakeholders.
Key Responsibilities
- Develop and execute regulatory strategies for assigned programs
- Provide regulatory guidance and support to cross-functional teams
- Interact with regulatory agencies and communicate with stakeholders
- Stay up-to-date with regulatory agency regulations and guidelines
- Identify and communicate regulatory issues to management
- Set and monitor submission timelines
- Facilitate and lead communications with regulatory agencies
- Develop and manage relationships with external regulatory agencies and industry groups
Qualifications
- Post-graduation in Clinical Pharmacy or similar
- Minimum of 10+ years of experience in global regulatory affairs
- Thorough understanding of NCE drug development process and regulatory requirements
This position is part of the Annual Performance Bonus Plan and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs, including medical, dental, and vision coverage, life insurance, disability insurance, and the employee assistance program.
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