上海招聘

GENERAL DESCRIPTION AND RESPONSIBILITIES

o Develop and execute regulatory plans for new/imported products
o Develop and document sound regulatory decisions and justifications
o Maintenance of licenses/authorizations according to country business needs
o Compile regulatory documents for submission according to local requirements
o Review, edit and proofread regulatory documentation
o Track status and progress of regulatory documentation
o Assist in preparation, review and training if necessary of labeling, SOPs, and other departmental documents
o Monitor applicable regulatory requirements; assure compliance with the company’s and external standards
o Compile and prepare responses to regulatory authorities questions
o Maintain regulatory files in a format consistent with requirements
o Establish communication and good working relationships within RA, other functions and the health authorities
o Maintain awareness of regulatory requirements
o Participate as an active team member of local/regional project teams as required
o Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
o May provide direct supervision of individuals
This job description does not list all duties of the job. Employees may be asked by supervisors or management to perform other duties.


MINIMUM REQUIREMENTS

o Bachelor’s degree or country equivalent in related scientific and related discipline from recognized institutions
o Minimum of 7 years of regulatory experience in RA or related field, including managing people or projects
o Strong knowledge of regulations in pharmaceutical products, medical device, health-related products, biologics
o Strong oral and written communication and presentation skills
o Ability to independently identify compliance risks and escalate when necessary
o Demonstrated interpersonal skills including strong negotiation skills
o Ability to manage complex projects and timelines
o Ability to multi task and prioritize
o Ability to lead and coach others
o Technical system skills (eg. word processing, spreadsheets, databases, online research)
o Good proofreading and editing skills and meticulous
o Good documentation and file management skills
o Ability to work under pressure and excellent in risk management
o Able to travel for work whenever required

* ABOUT US

EPS INTERNATIONAL CO., LTD (EPS INTERNATIONAL), a clinical service provider established by a reputable leading full service Japanese contract research organization – EPS Co. Ltd (EPS), commences its operations in 1999 to provide an integrated, seamless and optimal drug development platform through synergizing EPS’s long-established clinical resources and operations in Asia region to best support increasing outsourcing needs in the research, development and commercialization of pharmaceutical products and medical devices initiated by global and Japanese companies worldwide.
 
We have strong presence in Asia and are fast expanding our footprints in the Pacific, Europe and US.
 
Website www.epsgr.com
 
 
* COMPANY VALUES

In line with EPS’s corporate visions, EPS INTERNATIONAL aims to be an “Ever Progressing System” by continuously delivering quality clinical services, providing efficient and effective turn-key solutions for our Clients’ products development needs in Asia region.
 
 
* COMPANY SUCCESS
 
EPS INTERNATIONAL leverages and applies EPS’s values with many years of combined experiences as an added value to our Clients’ programs ranging from research, development to commercialization in key Asian countries. Lead by a great team of professionals with in-depth experiences and relationships supported by regional clinical networks, key opinion leaders and good performance sites, EPS INTERNATIONAL is the preferred outsourcing partner in Asia.

 
One of the large CRO in Japan and listed on Tokyo Nikki Stock Exchange. We are profitable and have strong and stable financial support from EPS Group.


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