Job Description

Primary Job Function This is a newly created position to support CMC activities for local and regional products within the Emerging Markets (EM) to ensure activities are completed consistently in a timely manner in accordance with Abbottu2019s policies, procedures and local regulations. Overall scope consists of providing CMC support to Regional and Affiliate Product Leads, primarily in: Drafts scientific CMC, and regulatory documents that conform to regional/local/global regulatory requirements, industry standards, and accepted templates. Extracts and summarizes scientific information from development reports and identify details required for regulatory submissions. Prepares, coordinates and manages the review and approval of documents by: Supporting the operation of the integrated review process Performing comment reconciliation to address and resolve issues Editing and creating updated drafts for the next phase of review in accordance with the established timelines Complies with Abbottu2019s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of Abbott Compiles and approves regulatory documents in collaboration with technical and operational stakeholders Manages review and approval regulatory documents engages members of relevant stakeholders to address and resolve issues in accordance with established timelines. Monitors and communicates actual versus planned regulatory activities and timelines Identifies and communicates risks and issues impacting project progression Maintains awareness of regulatory legislation and assesses its regional impact on business and Emerging Market Regulatory Affairs Builds and maintains strong working relationships with Regional and Affiliate Product Leads Provides accurate feedback to colleagues Ensures continuous compliance in alignment with Abbott procedures and regulations Maintains awareness of legislation and implement changes as relevant Ensure compliance with records retention (archiving) policy Takes steps to identify, communicate, and mitigate Regulatory CMC risks Support in streamlining and harmonizing operational related processes, Creates SOP delivers training as applicable. Identifies opportunities and suggestions for continuous improvements CORE COMPETENCIES Demonstrates general knowledge of technical/scientific principles and some specific knowledge of allocated products Shows general knowledge of global and regional regulatory requirements Shows flexibility and ability to work under pressure Reacts quickly to solve problems and issues when they arise Manages priorities and align with manager in case of conflicts/priorities Delivers high quality results. Meets agreed deadlines. Displays consistency Attempts to anticipate, mitigate and avoid problems and issues Seeks feedback from manager and team members and adapts behaviour to improve performance Develop an intrapreneurial mindset to identify new or unique ways to address work problems or opportunities Education/Qualifications/Experience Bachelor\'s Degree in pharmacy, biology, chemistry, pharmacology, or related subject A relevant masteru2019s degree is preferred Minimum 5 - 10 years of relevant experience in CMC activities Knowledge of Global regulatory procedures, CTD guidelines policies and standards Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity Detailed oriented, communication, compliance and process Improvement skills. Computer Knowledge: Knowledge of the Office package (Ms Word, Ms Excel, Ms Power Point)

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