Regulatory Affairs Manager

Ipsen (Tokyo, 日本) フォロー 9日前

今すぐ適用する

Title:

Regulatory Affairs Manager

Company:

IPSEN K.K.

Job Description:

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.

We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.

We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.

The RA manager is responsible to support the Ipsen KK Head of RA to ensure necessary information are prepared for RA dossier submissions to register drugs in Japan in compliance with local regulations and corporate guiding principles.

This role requires a strong understanding and knowledge of local regulations and requirements, experience in RA dossier preparation and submission, including for developing tactics to expedite product registrations, as well as strong communication skills with PMDA.

Main Responsibilities:

Manage product registrations to comply with local regulations and corporate guiding principles as well as appropriate submissions to register drugs to government officials.
Support RA Head of Regulatory in creating and implementing strategies and tactics to expedite registrations, contributing to the earliest possible introduction of products
Being able to lead the implementation and execution of the variety of all regulatory tasks from J-NDA preparation to submission and approval, as main responsible person.
Prepare for and carried out PMDA consultations in collaboration with Head of RA and global teams
Respond to queries from authority in a timely manner and take necessary regulatory actions leading to dossier approval
Review CMC and clinical data/information related to regulatory submissions
Strategically respond to drug price listing
Negotiate smoothly with authority to keep the milestone.
Communicate with counterpart in headquarters to progress the schedule.
Ensure compliance with proper procedures in the Regulatory Affairs in accordance with local and international laws, regulations, and corporate policies.
Register relevant technical & product changes according to change control process requirements.
Ensure the regulatory maintenance of products with the authority.
Responsible to ensure PMDA inspection readiness for GCP inspections and support adherence of clinical sites to Clinical operation processes in collaboration with global clinical operation team
Accountable for ensuring all activities are conducted in line with Ipsen ethics and compliance policies

Experience/Qualifications:

Education