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Regulatory Affairs Associate - II /Foster City, CA// 12  Months Long Contract Assignment
Ref No.: 18-36266
Location: Foster City, California
Position Type:Contract
Start Date / End Date: 07/16/2018 to 01/15/2019
Job Title: Regulatory Affairs Associate - II
Work Location: Foster City, CA
Length of Assignment: 12  Months Long Contract Assignment
Client:  A Big Pharmaceutical Company


Specific Responsibilities:
• Represent Regulatory Affairs on internal and external cross-functional teams, providing regulatory affairs support and strategy for investigational and/or marketed products for HIV, as assigned.
• Prepare IND and NDA submissions for assigned products, which may include routine submissions (e.g., safety reports, DSURs, PSURs/PBRERs, and NDA Annual Reports) as well as IND amendments and NDA supplements, as needed.
• Potential opportunity to support compilation and submission of new INDs and/or NDAs.
• Work within the department and with other functional areas on process improvements.

Essential Functions:
• Prepare regulatory submissions for assigned IND or NDA products, including routine submissions (e.g., PSUR/PBRERs, NDA Annual Reports, DSURs, RFIs, etc.) as well as IND amendments and NDA supplements, as needed.
• Contribute to preparation and filing of original IND and/or NDA submissions, as required.
• Engage cross-functional teams (internal and/or external teams) to develop submission strategies for US submissions (as required) in line with ICH/regional requirements and company policies and procedures.
• Support development and/or revision of product labeling (e.g., USPI, CCDS/CSI) in accordance with ICH/regional requirements and in alignment with company policies and standards, as needed.
• Participate in team meetings (e.g., study management teams and regulatory submission/project teams) for assigned products, including development of regulatory strategy and presentation of ongoing project updates.
• Under guidance of immediate manager, oversee self-development and acquisition of required regulatory skills and knowledge.
• Initiate and/or contribute to local process improvements which have an impact on the Regulatory Affairs function and/or other departments.
• As necessary, liaise with FDA for assigned projects/products.

Knowledge, Experience and Skills:
• Minimum of a BA/BS degree (an advanced degree is desirable)
• Minimum 4 years of experience in Regulatory Affairs or related field
• Excellent organizational, interpersonal, and communication skills
• Ability to work independently on multiple projects with tight timelines and minimal supervision
• General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories

If you are interested in this job than please send me your most updated resume on reena.sangwan@artech.com or you can reach me at #973-507-7579