Regulatory Affairs Associate

2 months ago


Foster City, United States Intelliswift Software Full time

Title: Regulatory Affairs Associate - II*

Location: Foster City CA- 3 days onsite

Duration: 6 Months on W2


Essential Duties and Job Functions:

● Spearheaded over 12 CMC submissions for commercial and investigational products, including vaccines and IMPD submissions to ROW countries.

● Facilitated cross-departmental collaborations, enhancing the efficiency and timeliness of regulatory submissions.

● Conducted strategic change control assessments, streamlining investigational and commercial product releases.

● Mastered and implemented Client-specific systems (RDMS, Insight, SharePoint, Veeva Vault, GRASP) to improve submission accuracy and regulatory compliance.

● Fostered strong interdepartmental relationships, significantly boosting submission process efficiency.

● Analyzed and adapted to scientific and regulatory developments, implementing strategic adjustments in response to the global regulatory landscape.

● Managed a wide range of regulatory submissions, from early clinical development phases through to global marketing applications and post-approval processes.

● Assessed regulatory impact of change proposals, optimizing compliance and submission strategies.

● Enhanced submission quality through collaborative authoring and review processes, focusing on compliance, scientific integrity, and thoroughness.

● Contributed to regulatory authority submissions, advising on content strategy and overseeing the management, review, and approval of critical documents.

● Compiled and updated annual stability, DSUR, and APQR reports, ensuring continuous regulatory adherence.

● Undertook additional responsibilities as needed, showcasing adaptability and



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