上海招聘

 Job Purpose*  

 This position has responsibility for Regulatory Affairs in defined portfolios or activity streams within their markets/areas. This includes 

 ·       Assist RA manger to ensure products within scope (inc medicines, devices, cosmetics and foods) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans 

 ·       Assist RA manger to ensure products are maintained and meet internal and external compliance requirements

 ·       Aligned with RA manager, to be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, eg, marketing/sales within local commercial business, supply chain and quality etc.

 ·       Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges 

 ·       Assist RA manager to provide  input into regulatory strategies and process improvement/compliance activities within defined areas of scope  

 Key Responsibilities 

 ·       Assist in managing preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market

 ·       Actively contribute to the activity of  a high performing local teams, including looking for ways to improve the performance 

 ·       Manage compliance within defined portfolio/activity streams in line with GSK CH expections -  support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements as well as local MoH regulations)

 ·      Work together with other functions ( eg, marketing, supply chain) to deliver NPD and value engineering projects ·       Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated 

 ·       Proactively provide assistance in managing impact of regulatory changes within defined scope of responsibility on the business 

 ·       Maintain required regulatory compliance databases, systems and processes 

 ·       Maintain high level of knowledge on the science of products within defined portfolio                       

About ExecuPharm

ExecuPharm, A PAREXEL Company, is a Global Functional Service Contract Research Organization, who provides clinical research support services for the pharmaceutical industry. ExecuPharm’s distinctive business model incorporates flexible models of service and technologies to support every aspect of a clinical trial.

ExecuPharm, with a core management team with extensive clinical operations experience, understands clinical trial challenges and how to solve clinical outsourcing, staffing, placement, technology and process needs.
 
21+ years of Experience Meeting Client Needs
16,250+ Global Clinical Operational Specialists In Network
80% of Recruiting Staff with >15 Years of Experience
Talent Acquisition, Deployment Rates, and Employee Retention above 90%
Management Staff with Tangible Industry Experience
Greater Than 95% Repeat Business
Average Turnaround Time of 14 Days To Deploy Project Team Resources

 
Global Capabilities

ExecuPharm’s clinical operations specialists are well versed in country and regional customs, business practices as well as regulatory and ethical restrictions and considerations. Having a resource that knows the culture, speak the language and is close in proximity to trial sites will aid in resolving any issues pertaining to the trial in a fast and efficient manner. ExecuPharm global locations are as follows:
 
King of Prussia, Pennsylvania, United States - North America
Mexico City, Mexico - North America
Buenos Aries, Argentina - South America
Chichester, United Kingdom - Europe
Bangalore, India - Asia
Shanghai, China - Asia
Tokyo, Japan - Asia


Mission

ExecuPharm was founded with the goal to support the requirements of clinical studies for all pharmaceutical and biotech's around the world. ExecuPharm’s expertise in the placement of staff and the conduct and management of all phases of clinical research and full drug development is attributed to our operational efficiencies, transparency in our partnerships and effective, responsive client service. These core values take the everyday burden and challenges of clinical studies off the clinical team, management and all stakeholders involved leading to faster, more cost efficient execution of studies.
 

Timeline

ExecuPharm has grown organically and strategically since 1995
1995: ExecuPharm founded
2005: Expansion of core services to include functional outsourcing (FSP) recruitment for specific functional areas in clinical research
2006: Awarded trial management personnel augmentation program
2007: Awarded FSP for all trial management activities
2008/2009: Further developed clinical operations department, adding multiple senior leaders from midsized and major pharmaceutical companies Significantly expanded corporate infrastructure to increase capabilities in IT, HR, QA and Recruiting
Expanded functional outsourcing services to include monitoring and site management

2012: Expanded services, with offices, into Europe and Latin America
2013: Expanded services, with offices, into Japan, China, and India
2014: Expanded services, with offices, into Mexico
2016: Acquired by PAREXEL