Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.

The Role:

Due to continued expansion and growth, we have an exciting opportunity for a Regulatory Affairs Manager to join our close-knit, dynamic and collaborative team. This role is responsible for leading liaison and negotiation with regulatory authorities through submitting dossiers and responding to queries from regulatory authorities, keeping up to date with changes in regulatory legislation and guidelines and ensuring that the company products comply with the Japanese regulations with having frequent communication with internal/external stakeholders incl. global HQ and partners.

Key Accountabilities:

• Identify each regulatory activity required from application to approval, create submission timelines, and manage project progress for J-NDA
• Evaluate data/documents provided by overseas partner companies (in English), conduct gap analyses with Japanese regulatory requirements, identify risks for J-NDA, and plan risk mitigation
• Create CTD and dossier to be submitted in an appropriate manner based on J-requirements.
• Conduct Life Cycle Management (MCN, PCA)

Major Tasks & Activities:

• Pipeline products: Conduct clinical trial consultations; understanding the structure and content of clinical study protocols and clinical study reports.
• Preparation of answers to deficiency letters after J-NDA submission until approval (Cooperation with overseas partners. Propose/input appropriate responses based on Japanese requirements)
• Ensure post-marketing product change management (minor notification, partial change application)
• Conduct regulatory due diligence for potential and new acquisitions product.

Requirements

• Experience in a series of development and regulatory affairs activities from development phase (definition of TPP, clinical trial etc.) and submission until approval (at least 2 products; experience with biological drugs is preferred)
• Experience with preparation and review of electronic format (eCTD) submissions.
• Understanding the structure of CTD (M1-M5) and necessary data/information for each module.
• Experience in clinical development, preparation of clinical study protocol and clinical study report.
• Experience in handling GCP compliance inspection or knowledge of GCP compliance inspection.
• Experience in communication with authorities ie. PMDA, MHLW (including clinical trial consultation, etc.)
• Experience in using FD application software.
• Experience in preparation of Package insert and updates of Package insert.
• Fluent level English – Meeting support in English (create slides, etc. and explain in English)

Interested? We would love to hear from you, please apply today for consideration.