Stellenbeschreibung
Associate Director Global Regulatory Affairs (m/f/d)
The Associate Director Regulatory Affairs provides global regulatory expertise to pre-clinical, clinical, and commercial areas for investigational and marketed products and ensures that regulatory/competitive intelligence, or scientific/regulatory information searching, summarization, assessment and dissemination are provided to the Otsuka organization. Furthermore, the Associate Director Regulatory Affairs collaborates with Regulatory Management to establish clear regulatory pathways and creates accurate and timely documents for submission and final approval.
Key Responsibilities:
- Global Regulatory Strategy: Providing strategic regulatory guidance, developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions, and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior Director or Executive Director or Head of Region Europe.
- Health Authority Liaison: Ensuring the primary contact to Competent Authorities within Europe and other regions as required.
- Regulatory Intelligence: Identifying the need for and obtaining regulatory intelligence, researching precedent approvals and prior health authority decisions to assess applicability in supporting the development of strategic options for assigned Otsuka products.
- Regulatory Assessment: Translating complex pertinent global requirements and providing an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed.
- Cross-Functional Leadership: Leading a cross-functional team to collaboratively develop a global regulatory plan, address global regulatory issues, respond to health authority queries, and meet regulatory obligations, with a focus on European requirements as needed per responsibility.
- Health Authority Interactions: Developing and leading strategy for Health Authority interactions/communications through submissions and responding to regulatory authorities within company timelines and in accordance with regulations and guidelines.
- Submission Document Review: Reviewing submission documents to ensure they are aligned with the strategic approach developed by the cross-functional team.
- Program Design: Designing programs for complete and accurate IND/CTA/NDA/MAA and other submissions, ensuring that clinical trials are designed to meet regulatory requirements.
- Compliance Support: Supporting development of strategies, drafting responses, and/or reviewing responses and documents intended for submission to health authorities to assure compliance with regulatory standards.
- Consistency Assurance: Reviewing submission documents for consistency and ensuring they are aligned with the strategic approach developed by the team.
- Agency Interaction: Interacting with regulatory agencies, ensuring conversations and communications are focused, amicable, and documented.
- Registration Support: Contributing to the submission of product registration of new drugs, progress reports, supplements, amendments, aggregate reports, and periodic adverse experience reports.
- Outsourced Supplier Oversight: Collaborating with and providing oversight to outsourced suppliers of regulatory support in the preparation of documents/reports.
- Issue Identification: Identifying early major regulatory issues and ensuring these are communicated to relevant stakeholders in a timely manner.