南京招聘

P O S I T I O N S U M M AR Y

? Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the area of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be in other related areas.

? May work either as part of Regulatory Submissions team or as part of the regulatory or cross-functional team depending on the assignment.

? Assist in the preparation, compilation and submission of regulatory submissions for healthcare products

J O B F U N C T I O N S / R E S P O N S I B I L I T I E S

The responsibilities of the Regulatory Affairs Officer include, but are not limited to:

? Be familiar with and work in accordance with relevant client SOP’s and client systems,

GXP and appropriate regulations and guidelines.

? Preparation, compilation of regulatory submissions and dossiers as required.

? Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.

? Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements

? Be able to solve the problems in pro-active and timely manner by identifying the deficiencies in the existing processes and procedures and providing the possible

solutions

? Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required

? Develop and maintain a current awareness of regulatory requirements through publications, seminars and appropriate training courses as deemed necessary

? Recognize, exemplify and adhere to DOCS's values which centre around our commitment to People, Clients and Performance

? As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our

business and meeting client needs.

? Other duties as identified and requested

C O M P E T E N C I E S

? Interpersonal – Communication – Clear

? Managerial – Result orientation – Prioritising

? Managerial – Planning and organising – managing

? Professional – Accuracy – Procedural

E D U C A T I O N , E X P E R I E N C E , S K I L L S AN D K N O W L E D G E R E Q U I R E M E N T S

QUALIFICATIONS

? Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.

? Good written and verbal communication skills

? Good written and spoken English

? Proficient in the use of Microsoft Office

? Due to the nature of this position it may be required for the employee to travel.

? Bachelor’s degree or local equivalent, in the sciences or relevant discipline or equivalent experience qualification.

EXPERIENCE & SKILLS

Industry experience in pharmaceutical/medical device marketing, clinical operation, or medical affairs would be preferred.

We are a global provider of consulting, and outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.