Temporary Regulatory Affairs Specialist (20-17231)
Job Description
“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”
Job Description: International Regulatory Affairs Specialist
This role is responsible for collecting, preparing, delivering and managing Module 1 documents in support of international market registrations through lifecycle to ensure accurate, consistent, and timely activities.
Position Responsibilities
• Works under the guidance of the Lead, Global Regulatory Collaboration & Service Center or Senior International Regulatory Affairs Specialist
• Collects, prepares and distributes required documents to ensure compliance with International Product Registration mandates, global Health Authorities and Client internal standards and requirements, utilizing USPI and other regulatory information
• Manages content and accuracy of critical Module 1 documents to meet health Authority requirements; these include Certificates of Pharmaceutical Compliance (‘CPP’s), Good Manufacturing Practice (‘GMP’) Certificates and Manufacturing Licenses, Price Certificates, and other documents such as US Certificate of Compliance with Foreign Law, Letter of Authorization or Notification, and declarations in support of marketing applications
• Manages these documents from Initiation through Lifecycle: this includes developing, cataloging and tracking all editorial, scientific and regulatory content and changes
• Prepares supporting documentation and arrange for legalizations, as required by country regulations.
• Builds real-time knowledge of global product registration documentation obligations and changes (Module 1); notifies GRS colleagues of potential changes, risks and mitigation actions
• Collaborates with contributing functional areas and external sources to verify accuracy of documents and certificates
• Collaborates with GRS-CMC, Country Regulatory Managers, Regulatory Strategists and GDM to develop action plans for timely preparation and management of Module 1 documentation; must ensure that correct and approved certificates are in use
• Builds up-to-date knowledge of extensive and complex global product registration requirements, assessing and communicating impact for Client business and products (working with Client policy groups as appropriate);
• Proactively identifies risks and issues, and supports development of solutions related to assigned projects / countries in order to support product lifecycle ancillary documentation
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Desired Experience Required:
• Bachelor or Masters in Life Sciences or related discipline 2years’ experience in pharmaceutical or scientific manufacturing document management
• Basic understanding of FDA Regulatory and Reporting regulations and standards; knowledge of global Health Authorities
• Must possess an excellent command of language (English) and professional knowledge of medical terms
• Good understanding of pharmaceutical or medical terminology
• Good communication and organizational skills and a meticulous eye for details
• Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar and willing to learn additional applications as needed
Ideal Candidates Would Also Have:
• Experience of the complexities of various regulatory requirements
• Project Management Experience
Other qualifications:
• US military experience will be considered towards industry experience requirements
How to Apply
Please send your updated resume to iris.chen@axelon.com866 total views, 0 today