Regulatory Affairs Officer 2(Beijing)
Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. With guidance from senior staff, provides regulatory support for more complex projects.
Acts as a Regulatory Team Leader on more complex projects, which may include technical writing.
Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.
Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate.
May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
May present to clients on complex regulatory processes at large full service bid defence meetings by phone or in person.
May act as reviewer for regulatory SOPs, as assigned and appropriate.
May prepare and deliver regulatory training to Quintiles small groups or individuals.
Performs other tasks or assignments, as delegated by Regulatory management.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Possesses a specific regulatory or technical expertise
Good, solid interpersonal communication (oral and written) and organisation skills
Strong software and computer skills, including MS Office applications
Demonstrates self-motivation and enthusiasm
Demonstrates negotiation skills and is confident in making decisions with minimal supervision
Ability to work on several projects, retaining quality and timelines
Ability to follow SOPs consistently; provides independent thought to assist in process improvements
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience* or high school diploma plus at least 7-9 years experience* (*or combination of education, training and experience)
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Travel will be required
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
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Quintiles is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential.
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