Senior International Regulatory Affairs Specialist

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

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. He / She will also advise on International Product Registration documentation requirements and priorities as the Subject Matter Expert to Global / US Regulatory, and other regulatory colleagues, as required.

• Collects, prepares and distributes required documents to ensure compliance with International Product Registration mandates, global Health Authorities and BMS 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.
• Maintains real-time knowledge of global product registration documentation obligations and changes (Module 1); notifies GRS colleagues of potential changes, risks and mitigation actions
• As Subject Matter Expert, advises Global / US / International Regulatory, submission teams on all International Product Registration requirements, and potential Module 1 document issues in order to meet regulatory requirements, timeline risks, and impact on patients and other stakeholders
• 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
• Maintains up-to-date knowledge of extensive and complex global product registration requirements, assessing and communicating impact for BMS business and products (working with BMS policy groups as appropriate);
• Proactively identifies risks and issues, and develops solutions related to assigned projects / countries in order to support product lifecycle ancillary documentation
• Contributes to BMS policy regarding country regulatory and policy changes as they relate to International Product Registration requirements

Required:

• Bachelor or Masters in Life Sciences or related discipline with more than 3 years' experience in pharmaceutical or scientific manufacturing document management
• Solid 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
• Robust knowledge of medical and scientific terminology, and biopharma manufacturing complexities
• Excellent communication and organizational skills and a meticulous eye for details
• Experience working on multi-disciplinary teams and projects
• Excellent and rigorous 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 US and other Health Agency requirements
• Professional knowledge of pharmaceutical and/or scientific documentation
• Notary Public certification
• Project Management Experience

Other qualifications:

• US military experience will be considered towards industry experience requirements