Summary & Purpose Of Position

• To coordinate the CMC regulatory strategy activities for the assigned projects throughout the different phases of development from early clinical trials to initial marketing applications, and life cycle management in Japan
• To manage the CMC Regulatory relationship with Global CMC to ensure alignment between Japan-Global CMC strategy.
• To execute CMC Module (QOS, MAAF,M3) finalization of J-NDA
• To execute post approval regulatory activity PCA (Partial Change Application) and MCN (Minor Change Notification).

Main Responsibilities

• Lead the development of CMC regulatory strategy (overall CMC regulatory roadmaps) for the assigned projects (new products in development and/ or commercial product(s) for both lifecycle management in Japan) ensuring the CMC reg risks are identified, assessed & shared as appropriate; and verifying the CMC regulatory requirements of Japan. Work efficiently with global CMC regulatory to ensure coherence of strategies across projects.
• Lead the preparation of the CMC part of the dossier for Japan by collaborating with CRO, to generate effective CMC regulatory dossiers as per the project timelines.
• Work closely with Japan Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of the assigned projects.
• Anticipate any gaps for planned regulatory submissions, taking into account emerging regulations and Japan specific requirements, prioritising and planning associated regulatory strategies to address any identified gaps.
• Communicate with Japan regulatory lead to propose to de-risking some CMC strategic decisions through early communications and validation with Japan health authorities.
• Lead the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
• Provide CMC regulatory expertise to project teams.
• Propose innovative CMC regulatory pathways to accelerate product delivery for patient enrolment in clinical studies, as required.
• Assess CMC-Regulatory impact of all changes proposed to the allocated product portfolio, providing strategic regulatory advice and clearly communicating any Regulatory impact and CMC-Regulatory supporting data requirements for subsequent variations/ amendments.
• Ensure collaboration with teams in Pharmaceutical Development and in Technical Operations, as well as with Subject Matter Experts (SMEs) to deliver (coordination, authoring and review) effective, timely and compliant, variations, responses to question and MAA modules 1, 2 & 3 in the correct "Ready For Submission" format for assigned products, in compliance with eCTD requirement.
• Work effectively with Japan Regulatory Affairs (JRA) Therapeutic area, to ensure that CMC-Regulatory submissions comply with Ipsen group policies and procedures. Ensure that submissions are planned and scheduled appropriately to align with Technical Operations implementation requirements or clinical supply needs, while ensuring adequate time for review, approval and publishing tasks. Ensure the consistency of CMC data across the different modules of the dossier.
• Assess CMC Regulatory activities and process performance, identify areas for improvement. Propose and lead continuous improvement process initiatives within the CMC-Regulatory Strategy function.
• CMC-Reg Strategy lead contact with external Alliance partners and CMOs ensuring aligned strategy and optimised communication as applicable.
• Manage all Regulatory interactions for Site Registrations, Site Licences, Site master files, annual reports and site accreditations with Regulatory Authorities, Alliance partners and CMO's for assigned product(s) as applicable.
• Perform CMC-Regulatory Intelligence activities as required and work with cross-functional departments to ensure related operations are compliant.
• Prepare and submit partial change application and minor change notification.

Knowledge & Experience

• A minimum of 10 years of experience in pharmaceutical/healthcare industry
• Proven CMC Regulatory experience in managing small molecules and/ or biologicals in Japan "(approximately 3-6 years' experience)".
• Experience should include registration and post-approval activities in Japan (PCA, MCN).
• Demonstrated experience in the development and implementation of global CMC-Regulatory strategies for major regulatory submissions.
• Strong project planning skills and ability to develop sound CMC-Regulatory strategy for multiple global changes.
• Proven advanced technical and regulatory writing experience with pharmaceuticals and familiarity with eCTD formats and publishing support functions.
• Sound technical knowledge of the manufacture of pharmaceuticals and appropriate understanding of all regulatory CMC disciplines.