Senior Manager responsible for identifying and pursuing opportunities among US - based Japanese clients for Kroll. Involves business development, client relationship management, and forensic investigations.
About the role
- Director of Regulatory Affairs leading drug product regulatory strategy and team management. Ensuring compliance and managing communication with FDA and regulatory bodies in a pharma environment.
Responsibilities
- Provides leadership, people management, and technical expertise for the regulatory affairs team supporting the business unit’s drug product.
- Interacts with the business unit’s cross-functional leadership team to support the direction, strategy, and growth of the organization.
- Responsible for drug development including global regulatory strategy, submissions, approvals, and regulatory and quality compliance.
- Creates long term regulatory strategy for drug products.
- Manages a regulatory affairs team responsible for the division’s pharmaceutical products.
- Accountable for the regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally.
- Provides regulatory guidance to and interacts with Marketing, Clinical, Legal, Operations, Compliance and R&D leadership.
- Leads communication with FDA and other regulatory agencies to gain alignment on most efficient regulatory pathways and gain product approvals.
Requirements
- Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related
- RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
- Minimum 15 years of experience, including 10 years in an FDA regulated industry
- 5 years of managerial experience preferred
- Experience with successful NDA and DINAs.
- Prefer additional experience with IDEs/ 510(k)s and/or combination products.
Benefits
- salary plus bonus eligible
- generally eligible for short-term and long-term financial incentives
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