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 he 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. The key responsibilities of this position are:

• 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

• Ensuring the primary contact to Competent Authorities within Europe and other regions as required

• Identifying the need and obtaining regulatory intelligence, researching precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products

• 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

• 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 including a focus on European requirements as needed per responsibility

• Developping 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

• Reviewing submission documents to ensure they are aligned with the strategic approach developed by the cross functional team

• Designing programs for complete and accurate IND/CTA/NDA/MAA and other submissions and ensuring that clinical trials are designed to meet regulatory requirements

• Supporting development of strategies, drafts responses, and/or reviewing responses and documents intended for submission to health authorities to assure compliance with regulatory standards

• Reviewing submission documents for consistency and ensuring they are aligned with strategic approach developed by the team

• Interacting with regulatory agencies and ensuring conversations and communications are focused, amicable and documented

• Contributing to the submission of product registration of new drugs, progress reports, supplements, amendments, aggregate reports and periodic adverse experience reports

• Collaborating and providing oversight to outsourced suppliers of regulatory support in the preparation of documents/reports

• Identifying early major regulatory issues and ensures these are communicated to relevant stakeholders in a timely manner

• Comprehensive knowledge of the drug development process, drug laws, global regulations, and guidelines

• Good understanding of the global regulatory agencies

• Experience leading submission of CTA, IND, sNDA/NDA/MAA/Variations

• University degree in Medicine, Pharmacy, Life Sciences or Chemistry

• Several years of clinical/industry/health authority or otherwise relevant experience, preferably in a global or at least European role.

• Good CMC knowledge

• Experience in one or more of the therapeutic fields: Oncology, CNS, Cardio-Renal

• Strong information searching, summarization and assessment skills

• Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).

• Strong analytical skills and problem solving ability

• Strong communication and presentation skills with an excellent command of the English language

• Experience in working in, and communicating with cross-functional, multi-cultural project teams involving internal and external experts.

• Strong knowledge and experience in European Regulatory Affairs encompassing strategic and operational aspects