Associate Director Global Regulatory Affairs (m/f/d)

Overview

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 theAssociate 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:

Key Responsibilities

• Providingstrategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managinglifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior Director or Executive Director or Head of Region Europe

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

• Identifyingthe need and obtainingregulatory intelligence, researchingprecedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products

• Translatingcomplex pertinent global requirements and providingan 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

• Developpingand leadingstrategy for Health Authority interactions/communications through submissions and respondingto regulatory authorities within company timelines and in accordance with regulations and guidelines

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

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

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

• Reviewingsubmission documents for consistency and ensuringthey are aligned with strategic approach developed by the team

• Interactingwith regulatory agencies and ensuringconversations 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 providingoversight to outsourced suppliers of regulatory support in the preparation of documents/reports

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

Qualifications

• 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