- Full-time
- Responsible for the submission of global regulatory documents
- Manage the compilation and archiving of regulatory submissions
- Assist with setting up submission templates and troubleshooting MS Word, Adobe PDF documents, electronic document management system, pubishing tool, and databases
- Function as a publishing resource for Regulatory Affairs
- Maintain and control regulatory submission electronic filing system, user management, and correspondence logs
- Create and manage SOPs/Work Instructions/User Guides affecting job function
- Responsible for assisting with Document Control Room activities
- Assist with computer system validation activities
- Interact with external vendors, regulatory team members, cross-functional departments and teams
- Manage special projects as necessary
- Fluent Japanese and English communications skills, both orally and in writing
- Knowledge of Microsoft Office Suite, Adobe, and databases
- Working experience in Pharmaceutical idustry
- Ph.D, Master or Bachelor degree of Pharmacy
- One to two years of office experience required
- Associate's Degree or equivalent industry experience
- Strong organizational skills and attention to detail
- Ability to understand and adhere to document control procedures
- Strong proofreading skills and ability to recognize deviation from accepted practice
- Ability to work as a team player when assigned to a project assignment
- Ability to focus despite distractions and changing priorities
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Regulatory Operations, Specialist - Osaka, 日本 - Santen Inc
説明
Regulatory Operations, Specialist
Company Description
Position can be based at any Japan Santen office. Open only to internal applicants. Please submit English CV.
Steps:
screening→SPI→CV review→explaining session→1st ITV→2nd ITV
Job Description
This position is responsible for assisting regulatory operations group with preparation, organization, publishing, and archiving of global regulatory documentation for submissions to the regulatory agencies. Prior regulatory experience is not required. On the job training will be provided.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
Qualifications
Mandatory:
Nice-to-have:
Additional Information
Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
