RA Director

Job Purpose

The job holder manages specified aspects of regulatory work. The Director Regulatory Affairs Japan is responsible for providing input on Japan strategy and ensure the Global Core Team’s strategy and submission components meet the Japanese Health Authority requirements and marketed product registrations as well as licensing opportunities covering Japan.

· Provide input into Japan RA strategy, submission requirements and associated timelines in alignment with GRA (Global Regulatory Affairs).

· Clearly highlight any associated risks along with mitigation strategies

· Be the primary point of contact with the Health Authority (i.e., PMDA and MHLW) and CROs supporting Japan activities if required.

· Ensure compliance with any local requirements dictated by the PMDA and/or MHLW guidance documents and inform global team.

· Ensure MAH (Marketing Authorization holder) license and establish MAH organization in Japan

· Ensure Japanese Accepted Names for Pharmaceuticals (JAN) by project.

· Responsible for submitting regulatory documents or data package to the PMDA or MHLW (either directly or via partner/CRO)

· Responsible for translation of English documents into Japanese. Responsible for managing and archiving the Japanese version of the document. Provide the final translated Japanese version to global team for archival purpose.

· Keep GRA Strategist in the loop (i.e., emails, meetings, discussions etc) on regulatory matters to ensure effective collaboration and successful execution of Global Core Team’s Japan strategy.

· Coach and mentor junior regulatory staff members where appropriate or as needed by the line management.

· Keep line management and Global Core Team up to date on the status of regulatory strategies, submission and approvals and any risk and mitigation strategies.

· Be able to provide hands on support where needed and have can-do attitude.

· Ensure business case relating to product expansion in Japan is shared with the GRA Strategist

· Coordinate with the Health Authority to facilitate meeting date and logistics.

· Review and input into the briefing book to ensure it meets the local requirements.

· Partner closely with the GRA strategist to ensure submission strategy/TOC meets the Japan requirement

· Share local submission tactics including Module 1 requirements.

· Ensure label/artwork drafted by Global Functions meets the local requirements.

· To align and support GRA Strategist on labelling preparations and revisions to ensure it meets local requirements including translations from English to Japanese

· To support GRA Strategist on the submission documents review for CMC changes

· Inform GRA Strategist on any CT related document submitted due to change or issues if required.

· Provide Japan regulatory intelligence to the project team member

Analysis

• Demonstrates the ability to evaluate critical data to identify the cause of a problem, seek appropriate expertise, and resolve or facilitate resolution. Thinks through consequences of different courses of action. Exhibits leading edge or novel ways of thinking.

• Ability to work independently and flexibly.

• Able to facilitate effective strategic planning interactions and discussions.

• Able to effectively interact with external parties to information gather and effectively drive projects through to completion within tight timelines.

Communication

• Must be able to facilitate effective interactions within the Global Regulatory Affairs team, as well as with other departments and sites within the company and affiliates, and partners (as appropriate).

Customer focus

• Anticipates and understands the needs of internal and external customers.

• Business awareness and professionalism

Delivery and results

• Must have a "can do", flexible attitude and be "hands on" as when required.

• Able to focus on key objectives. Able to make informed decisions, based on risk and consequence analyses. When developing submission work, able to prioritise tasks with the team.

Flexibility/ adaptability

• Ability to manage ongoing change. Able to adopt means of communication and interaction to people from different cultures.

Team working

• Able to influence through pro-active communication and to negotiate effectively.

• Able to command respect at all levels and cultural interfaces.

Technical

• Knowledge of new drug development process

• Knowledge of project management

• Knowledge of regulations from Non-Clinical, Clinical, CMC and post-marketing requirements phase (e.g. License, Labelling, Ad-Promo, Distribution, Narcotics

Requirements

Education Required:

• PharmD, Ph.D. or Master's degree

• Minimum 10 years of relevant experience in regulatory Affairs.

• Direct experience of working in the APAC region primarily Japan.

• Proven experience of making new marketing authorisation applications and post-marketing activities in Japan.

• Experience of interactions with Regulatory Authorities within the APAC region (i.e. primarily PMDA, MHLW and scientific/medical bodies in Japan).

Experience Preferred:

• Evolving understanding of regulations/guidelines governing development of pharmaceuticals