Global Submission Associate

Job Overview Job Title: Global Submission Associate – Morristown, NJ The Global Submission Associate coordinates lifecycle submissions for the global portfolio, working directly with key stakeholders, GRA focal points and publishing partners to ensure the submissions are prepared on-time and with high quality while meeting Health Authority (HA) specifications. The role partners with Submission Managers and Submission Leads to support the publishing and delivery of complex submission plans. Accountable for 3rd party publishing interactions, training, QC, and workload prioritization. The associate also provides publishing subject matter expertise to project/product teams and drives continuous improvement initiatives. Main Responsibilities Coordinate lifecycle submission requests for the global portfolio, working directly with key stakeholders, GRA focal points, local affiliates, and publishing partners to ensure the submissions are prepared on-time and with high quality while meeting HA and regional requirements. Partner with GBU and regional submission platforms to achieve and execute GSS plans and delivery, utilizing content re‑use strategies and applying technical expertise. Provide guidance to project teams on developing submission structure strategies in accordance with HA and ICH regulations, guidelines and specifications. Collaborate and support third‑party vendors as needed to support submission efficiency and overall success. Prepare, compile and review regional submission documentation to regulatory health authorities according to ICH/eCTD format and submission‑ready health authority standards, as well as Sanofi standards. Ensure end‐to‐end process adherence for routine compliance submissions. Perform quality control checks for submission publishing, understanding and addressing validation criteria in detail, and troubleshooting. Assist in improvement efforts of publishing processes and contribute to review and updates of quality documents. Identify and raise submission technical issues in a timely manner to ensure that resolutions are realized, enabled and executed to deliver according to planned submission filing dates. Maintain knowledge of regulatory requirements for document and submission assembly and publishing across various submission regions on a continuous basis. Qualifications Basic Qualifications: Bachelor’s degree in regulatory affairs, sciences, or related areas. Other fields (e.g., business administration, economics, law) will be considered if the candidate has publishing experience. 3+ years of experience in the pharmaceutical industry, with direct regulatory affairs experience. Proficiency in eCTD publishing tools and platforms. Knowledge of regulatory submission requirements for at least one of: US, Canada, or EU. Dossier assembly and technical standards (eCTD structure, modules). Preferred Qualifications: Working knowledge of drug laws, regulations and guidelines is essential. Proficiency in publishing and technical review of Module4 and5 datasets is essential. Understanding of global regulatory requirements, global submission processes (re. EMA work sharing) and drug development process. Familiarity with document management systems (e.g., Veeva), RIM systems and DMS systems. Ability to learn quickly and adapt to new technologies/environments. Self‑starter, who motivates and negotiates with an agile and positive approach. Ability to implement and manage global regulatory technology solutions to streamline processes. Ability to identify critical technical issues and propose creative and achievable solutions through technical expertise and troubleshooting. Strong attention to detail and accuracy. Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization. Ability to operate with agility in a dynamic global environment. Ability to maintain discretion and confidentiality about sensitive data. Ability to communicate and collaborate on many levels, including issue escalation to GRA leadership. Ability to work across cultures. Location Restrictions US and Puerto Rico Residents Only. North America Applicants Only. Salary and Benefits The salary range for this position is: $75.000,00 - $108.333,33. All compensation will be determined commensurate with demonstrated experience. Benefits include high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral parental leave, among other health and wellbeing benefits. Equal‑Opportunity Employment Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiantative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #J-18808-Ljbffr