Senior International Regulatory Affairs Specialist

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Job description

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Responsibilities:

• 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

Qualifications:

Required:

• Bachelor or Masters in Life Sciences or related discipline ³ 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

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.