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RA Director, Pharma, 15M
- Lead a 10 person Regulatory Affairs division
- US Pharma Industry, Tokyo location
About Our Client
Our client is a company growing exponentially, yet they retain an entrepreneurial spirit. Everyone they hire is crucial to the company's success. This company is a place where everyone is connected... to each other, to the patients and their caregivers, and to each others families. So once you get there, you'll want to stay (there's extremely low turnover). Why? You'll be empowered to do the best work of your career.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
Develop and implement sound national and international regulatory strategies for multiple products.
Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies including leading the preparation of briefing documents
Write paper and electronic submissions, as applicable, to support development project plans and timelines for IND, CTAs, NDA, and MAA and related submissions, as well as amendments and supplements to these applications and responses to regulatory agency requests.
Collaborate with responsible departments and leads preparation, review, and collection of documentation for regulatory submissions.
Provide critical review of all documentation supporting regulatory applications.
Work with peers to develop standard operating procedures and departmental guidelines.
Develop and manage regulatory project specific timelines, in keeping with Corporate objectives and actively participates on project teams advising on submission preparation timelines, processes, and requirements.
Review and approve protocols, reports, and documents used in regulatory submissions.
Mentor regulatory associates and managers.
The Successful Applicant
Experience and Skills:
Bachelor's degree in Biology or Chemistry, advanced degree preferred
15 years of industry knowledge experience (pharma, biotech, CRO).
5-10 years of regulatory experience, NDA/MAA filing experience preferred
Required Knowledge and Abilities:
Strong verbal and written communication skills are essential in Japanese and English
Excellent organization and multi-tasking skills.
Exceptional interpersonal skills and problem solving capabilities.
Proven negotiation skills.
Ability to work effectively across a matrix organization.
Ability to work independently and prioritize with minimal daily instruction.
Ability to think strategically in order to improve current processes
What's on Offer