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Regulatory Affairs Associate - II
Ref No.: 18-09876
Location: Foster City, California
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