Global Submission Associate

Sanofi•Cambridge, MA

5d•$75,000 - $108,333•Onsite

About The Position

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. 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 Global Submission Associate also provides publishing subject matter expertise to project/product teams and continuous improvement initiatives. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Requirements

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).

Nice To Haves

Working knowledge of drug laws, regulations and guidelines is essential.
Proficiency in publishing and technical review of Module 4 and 5 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.
Maintain independent abilities 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

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 into global submissions.
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 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.