Regulatory Affairs Associate
2 months ago
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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Regulatory Affairs Associates
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Regulatory Affairs Associates
1 month ago
Foster City, United States Infotree Global Solutions Full timeOne of our leading Pharmaceutical client is looking for a Regulatory Affairs Associates (Data), who will be responsible for performing data entry using client Information Systems to enter and maintain relevant product information to support cross-functional stakeholders.Job Title: Regulatory Affairs Associates (Data)W2 Contract & Onsite roleWork Location:...
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