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: Regulatory Affairs Officer 1/Regulatory Affairs Officer 2-1415417
Job Description
PURPOSE
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.
RESPONSIBILITIES
• 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
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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
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)
Additional Information:
Experience: Min. 3 year
Location: Bangalore- Karnataka
Last Date: 20th August, 2014
Job Id: 1415417
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