Senior Regulatory Affairs Manager

GE (Tokyo, 日本) 5日前

We are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world’s toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people’s lives. With every weld, every sale, and every code we write we keep the world in motion. It’s time to stop dreaming about the future; let’s build it together.

RA Manager works with RA professionals responsible for pharmaceutical product registrations, and for the provision of regulatory guidance in assigned area. He or she reports to the APAC RA leader and GMCO (General Marketing Compliance Officer in Japan).

Job Description

Essential Responsibilities :
RA Manager leads National RA.
1. Develop regulatory strategies which meet business goal
2. Lead product registration and labeling revision
3. Lead PMDA meeting and CTN submission to perform clinical trial
4. Support Global R&D to develop Clinical Development Plan
5. Provide proactive regulatory advice and support to stakeholders
6. Monitor new RA requirements and proactively provide stakeholders with regulatory guidance
7. Establish effective communications and processes with stakeholders
8. Build effective working relationships with regulatory agency, industry associations and business partners

Qualifications/Requirements :
1. Minimum 5 years’ work experience for RA at pharmaceutical industry
2. Ability to communicate effectively in Japanese and English (both written and verbal)

Desired Characteristics :
1. Demonstrated ability to influence all levels of stakeholders at a multi-national organization
2. Demonstrated knowledge and experience for Japanese regulatory environment in pharmaceutical area
3. Demonstrated ability to work with cross-functional and cross-regional teams
4. Demonstrated problem-solving ability

Additional Eligibility Qualifications :

Relocation Assistance Provided: No

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