Director of Regulatory Affairs
- Lead the development, implementation & direction of effective regulatory strategies with oversight for all regulatory functions (pharmaceutical, biologics and/or device programs).
- Provide leadership to ensure site expectations are met by providing regulatory vision, strategy & planning relevant to CMC (premarket & post-approval), compliance & policy.
- Provides program oversight and CMC regulatory strategy to global programs in various stages of development.
- Strong focus on analytical, manufacturing, and facilities compliance.
- Interfaces cross-functionally both within the regulatory affairs team as well as with other teams (commercial, clinical development, delivery, quality, etc) to ensure that data are identified, obtained and effectively presented for the registration of products globally.
- Demonstrates leadership and comprehensive understanding of global CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to identify, communicate, address, and overcome challenges that arise during development and commercialization.
- Conduct routine regulatory surveillance and coordinate comments on new/changing regulations globally.
- Successfully communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
- BIOLOGICS experience
- Pharmaceutical experience
- 10 years of direct experience
- Minimum, 5 years supervisory/managerial experience
- Bachelor Degree (science or healthcare preferred)
- FDA Regulated Industry experience (minimum, 10 years in pharmaceutical, medical device or healthcare industry)
- Regulatory CMC experience
- Strong project management
- Relevant filing experience with proven experience managing BLA submissions to approval (Medical device 510(k) is desired)
- Experience leading negotiations and health authority interactions with FDA, Health Canada, EMA, TGA, etc.
- Advanced, in-depth technical knowledge & solid understanding of relevant FDA & USDA federal, state and local regulations as well as ISO standards
- Able to negotiate resolution to challenges impacting Regulatory compliance and assist in creating rationale strategies to guide the organization
- Requires an understanding eCTD requirements and experience in writing, preparing and submitting relevant CMC documentation.
- Masters with an Emphasis in Regulatory, Business or Scientific Discipline
- Allergenic or immunology experience