Senior Executive, Compliance

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ADVANZ PHARMA

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🤝 B2B

💰 Post-IPO Equity on 2024-02

Pharmaceuticals • Healthcare Insurance • B2B

ADVANZ PHARMA is a global pharmaceutical company dedicated to improving patients’ lives through the provision of specialty, hospital, and rare disease medicines. With a presence in over 90 countries, the company partners with innovative biopharma and pharmaceutical development firms to commercialize its extensive product portfolio, which includes innovative medicines, specialty generics & biosimilars, and originator brands across various therapeutic areas. Headquartered in London, UK, ADVANZ PHARMA operates with a strong commitment to entrepreneurship, speed, and integrity, seeking to broaden patient access and enhance health outcomes through strategic partnerships.

📋 Description

• Owning Compliance related change controls pertaining license updates and ensuring such changes are progressed and closed within timelines. • Establishing business and Quality needs and criticality for identified license non-compliances and closing license gaps as dictated by this information. • Writing supporting Quality related submission documents, as necessary. • Managing workload appropriately with the ability to re-prioritize rapidly as necessary. • Liaising with Regulatory routinely to ensure submission priorities are aligned and quality critical submissions are prioritized. • Reviewing and approving critical Module 3 documents written by Regulatory prior to submission to ensure content is CTD compliant. • Managing associated submission RFIs within timeframe. • Quality Compliance owner for Technical Transfers projects, involving performance of gap assessment between prospective CMO and current registered information and working toward established project timelines. • Liaising with external stakeholders including Contract Manufacturing Organizations and building key relationships. • Quality Compliance SME for Projects owned by both the Compliance team and other departments.

🎯 Requirements

• Minimum Degree in Chemistry, Pharmacy or Microbiology • Minimum 5 years' experience of working in a similar role within a pharmaceutical industry • Extensive GxP knowledge across all dosage forms • Experience in authoring Module 3 in CTD format • Experience in interpreting manufacturing and testing information (Critical Vs. Non-critical) for submission purpose • Experience in ensuring that accurate, adequate and appropriate data is incorporated in Module 3 so as to ensure right first submissions • Experience in writing supporting submission documents (e.g. justifications to support post marketing changes and response (to RFI) • Extensive knowledge of QMS, specifically change controls and risk assessments, and continuous improvements • Capable of working to deadlines & remain calm under pressure • Proven ability to organize and prioritize multiple tasks • Ability to work effectively as part of a team and cross functionally

🏖️ Benefits

• Competitive salary • Flexible working environment