Job Description

Company Overview
Pharmaceuticals Company

Job Description
• Formulate & implement Regulatory strategies and plans to achieve efficient &
competitive product development
• Provide regulatory direction for the coordination, and preparation of regulatory
submissions consistent with regulatory requirements to meet corporate strategy & timelines
• Provide regulatory input into cross-functional Project Teams for product development and submission activities
• Act as regulatory lead for the review of documentation prepared by other technical functions
• Provide regulatory review and approve of internal documentation supporting product development activities (e.g. clinical protocols, clinical study reports, statistical analysis plans, etc.)

• Minimum 8 years Regulatory Affairs experience in the pharmaceutical or
biotechnology required
• Experience with inhalation products would be a plus
• Strong regulatory knowledge of drug development, clinical trial requirements, design and analysis, post-marketing surveillance, manufacturing (ideally with drug- device combinations), quality, marketing and sales.
• Diverse and sufficient technical expertise to be a credible interface to all development and business partners (CMC, preclinical, clinical, statistician, market access specialists, legal, etc.).
• Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
• Must have excellent communication and presentation skills (verbal and written / Japanese and English) with the ability to effectively present ideas and influence others that achieve desired results