29-07-2024
Job Type
Permanent
Emp Type
Full Time
Functional Expertise
Regulatory Affairs
Salary Type
Annual
Job Description
Title: RA Senior Specialist - New Drug Development
Location: Tokyo, Japan (Hybrid)
***The eligible candidate must have experience in Japan RA***
Job Description
Primary Activities:
- Develops new drug regulatory strategy for Japan from early Phase to Life Cycle Management (LCM) activities (i.e.: new indications, line extension, major efficacy variations aligned with regional priorities
- Collaborates with commercial and local stakeholders to align regional regulatory strategy with country priorities.
- Communicates program information with Country team to facilitate developing local regulatory strategy. Identifies the best possible regulatory strategy options in discussion with the countries for filing and pre-submission requirements/support needed from global teams.
- Primary communicator with Regulatory Franchise and Global product strategy team members on key strategic issues (including updated guidelines/requirements) for Japan / regional countries and ensuring any updates are communicated in a timely manner.
- Responsible as a point of contact to local Health Authority (PMDA)
- Oversee external service providers.
This position needs communication and teamwork skill with responsible functions in local and global.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Other activities:
- Be a SME for RA related system and/or procedures if required
- Be a point of contact for RA/ORD related inquiry/communication from local HA and/or hospitals if required
- Working in matrix environments including global teams
Required Education, Experience, and Skills:
- Bachelor’s degree and at least 15 years of pharmaceutical industry experiences including at least 3 years of directly related experience, OR
- Master’s degree and 10 years of pharmaceutical industry experiences including 3 years of directly related experience.
- Thorough, knowledge of regulations pertaining to new drug registration and risk/ safety standards is a pre-requisite.
- New Drug Strategy leadership is expected to have strong leadership, communication, decision making, and problem-solving skills.
- Japanese: Native level, English: Business level