Life Science graduates can apply for Regulatory Affairs Associate @ Quintiles

Job Title : Regulatory Affairs Associate
Job Description :

Purpose :

Assists in the preparation and/or review of regulatory documents and submissions. Serves as a regulatory member on project teams, under guidance of senior staff. Provides regulatory support for assigned projects.
Job Responsibilities :

• Creates an inventory of appropriate regulatory documents based on checklists prepared by Regulatory personnel.
• Identifies project needs, tracks project timelines and implements client requests, with senior review.
• Reviews documents for regulatory completeness, consistency and accuracy, interacts with project team members to assure completeness, as necessary.
• With oversight may draft text for straightforward regulatory documents, and conduct QC review of documents prepared by the regulatory unit, project team or client.
• Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with senior staff.
• May work independently with internal clients and may interact with external clients, under guidance of senior staff.
• Assists with project budget, project management, business development activities and other tasks as required by senior Regulatory team members.
• May address technical issues with documents and offer assistance to staff.
• Performs other tasks or assignments, as delegated by Regulatory management.

Skills and Abilities : 

• Good, solid interpersonal communication (oral and written) and organization skills
• Strong software and computer skills, including MS Office applications
• Above average attention to detail and accuracy
• Working knowledge of regulations and guidances relevant to the area of expertise
• Ability to work on multiple projects, with direction from senior staff as appropriate
• Ability to adapt quickly to a rapidly changing environment
• Ability to follow SOPs consistently
• Ability to make decisions on discrete tasks under senior supervision
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
• Experience with some, and/or, all of the following:-
• Support the delivery of IND and NDAs for the developed & emerging markets
• Support IND update filing, EU lifecycle maintenance activities
• Support the provision of core CMC and preclinical documentation for regulatory filings
• Prepare and organize Module II/III/IV/V of CTD as per ICH requirements
• Prepare and organize documents in ASEAN CTD format
• Experience with global labeling requirements
• Risk Management Plan (RMP)/Periodic Benefit-Risk Evaluation Report (PBRER) writing for EU

Reg Affairs Associate-1317572

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