Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post: Reg Affairs Associate-1317572
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.
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.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, 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
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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
Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Degree in life science-related discipline or professional equivalent* or high school diploma plus at least 3-5 years experience* (*or combination of education, training and experience)
Additional Information:
Experience: 3-5 year
Location: Karnataka-Bangalore
Functional Area: DRA
Last Date: 28th February, 2014
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