Director – Regulatory Affairs Strategy-Oncology

Director – Regulatory Affairs Strategy-Oncology

Requirements

• Bachelor’s degree in scientific discipline required.
• Advance degree (M.S., PhD, Pharm D) is preferred.
• Minimum eight plus (8+) years direct Regulatory Affairs experience within the biopharmaceutical industry, including leading Health Authority meetings and submission of marketing applications in the US (required), EU or JP (desirable).
• Demonstrated knowledge of regulatory requirements and guidelines, including FDA, ISO, and EU MDR.
• Strong written, verbal, and presentation skills, with the ability to effectively communicate regulatory data to cross functional teams and senior management.
• Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.

Responsibilities

• Lead/support Regulatory Affairs Functional Teams (RAFTs) to ensure the highest quality strategic regulatory input is provided to optimize regulatory outcomes and maximize product value.
• Lead development and creation of global/regional regulatory strategies for multiple clinical development projects at all stages (Phase I through market authorization).
• Author and / or review regulatory documents for submission to US/Canada, and/or Rest of World regulatory agencies in support of formal meetings with health authorities and major applications (INDs / CTAs, NDAs / BLAs / NDSs / MAAs, orphan designation, etc.).
• Provide oversight of external partners and deliverables to ensure compliance with regulatory requirements and alignment with global regulatory strategy.
• Provide leadership and strategic input to the Filing Submission Team and lead other project sub-teams, as assigned.
• Lead the preparation for and conduct of formal Health Authority meetings with KKNA Regional Regulatory Lead including the review of applications and negotiations with Health Authorities.
• Provide regulatory expertise, advice, and requirements for pre-clinical and clinical disciplines, in support of drug candidates under development either on project teams or management committees.
• Create and maintain Regulatory Strategic Development plans and provide strategic input to global project development plans.
• Identify and escalate potential regulatory issues to executive management and propose risk evaluations and mitigation strategies.
• Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed.
• Research regulatory requirements to support submissions or inquiries from functional groups.
• Remain current on changes in regulatory requirements and environment and be a resource to functional groups for regulatory information.
• Prepare and review SOPs / WIs to achieve consistency in regulatory standards and compliance.
• Assure that all aspects of the Company’s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.

Preferred Qualifications

• Oncology experience highly desired.
• Experience in EU or JP regulatory affairs is desirable.