JOB DESCRIPTION:
Job Title
CMC Specialist (outsourced opportunity for 3 years)
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of . A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our [insert location of working site] in the Established Pharmaceutical Division where we are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
This position supports the various aspects of marketing authorization submission management processes. Will help manage submission content for Drug Substance and Drug Product, and to provide guidance on structure and content placement within CTD registration submissions and to provide assistance with submission related to Egyptian Drug Authority.
What You’ll Do:
Develop, plan and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with EM-CMC Regulatory Scientists and other functional representatives, such as TS/MS (process and technology transfers), manufacturing, quality control and quality assurance. Be a responsible party for preparing CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements. Partner with the EM-CMC Regulatory Scientist to plan and prepare submission content for marketed products to support management of post-approval changes. Manage submission timelines with relevant teams (e.g. supply chain, QC, manufacturing), monitor approval status and communicate change status in a timely manner. Partner with Affiliate RA to effectively support product lifecycle maintenance such as site registrations, Tech transfers, products renewal as well as license expiry, where applicable. In conjunction with Affiliate Regulatory Associates and EM-CMC Regulatory Scientists, may be involved in the management of some GMP documents, if applicable. Review/Approve regulatory documents such as: full and core CMC Dossiers (via Darius), variation packages, post-approval commitments with Egyptian Drug Authority and answers to questions received from EDA. Create an environment within the Regulatory Area and CFT that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues. Leverage internal forums to continue to develop and share regulatory expertise to meet critical product registration timelines and CTD submission structure and content requirements. Communicate effectively to guide and influence within work group/function regarding life-cycle management processes Change Control management: preparation of change control request form (CCRF), regulatory & Cross functional assessment vis Track wise system.
Required Qualifications
Bachelor’s in general science, Pharmaceutical Science, Related Science Excellent knowledge of written and spoken English and fluent in Arabic. Computer skills including Microsoft office Good communication skills and ability to prioritize Able to make decisions that impact own priorities and allocation of time to meet deadlines Accuracy, attention to details, reliability, punctuality, and problem-solving skills Ability to work in a matrix organization Good team spirit and familiar with project development through cross-functional activities Strong organizational and negotiation skills Ability to establish and maintain good regulatory networking internally and externally Pro-active and well organized with good sense of responsibility Balanced Judgment / Risk based approach Analytical thinking, hands-on troubleshooting style
Preferred Qualifications
2-3 years working experience in CMC regulatory affairs Writing of technical reports In depth knowledge of ICH Guidelines and Egyptian Drug Authority regulations Experience in providing CMC support of new and/or marketed pharmaceutical Ability to provide input, guidance and recommendations in the preparation of the dossiers from different sources to give uniformity of filing.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory
DIVISION:
EPD Established Pharma
LOCATION:
Egypt > Cairo : KTC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
