Global Submission Associate
Sanofi
15 days ago
Remote friendly (Morristown, NJ)
United States
$75,000 - $108,333.33 USD yearly
Operations
Main Responsibilities:
- Coordinate lifecycle submission requests for the global portfolio to ensure on-time, high-quality submissions meeting Health Authority (HA) and regional requirements.
- Partner with GBU and regional submission platforms to achieve/execute GSS plans and delivery using content re-use and technical expertise.
- Guide project teams on submission structure strategies in line with HA and ICH regulations/specifications.
- Support third-party vendors to improve submission efficiency.
- Prepare, compile, and review submission documentation for regulatory health authorities using ICH/eCTD and “submission-ready” standards.
- Ensure end-to-end process adherence for routine compliance submissions.
- Perform QC checks for submission publishing (validation criteria, troubleshooting).
- Support publishing process improvement and updates to quality documents.
- Identify and raise submission technical issues to enable timely resolutions ahead of filing dates.
- Maintain ongoing knowledge of regulatory requirements for document/submission assembly and publishing across regions.
Qualifications:
- Bachelor’s degree in regulatory affairs, sciences, or related area (other fields acceptable with publishing experience).
- 3+ years pharmaceutical industry experience with direct regulatory affairs experience.
- Proficiency in eCTD publishing tools/platforms.
- Knowledge of regulatory submission requirements for US, Canada, or EU.
- Dossier assembly and technical standards (eCTD structure/modules).
Preferred Skills:
- Working knowledge of drug laws/regulations/guidelines.
- Proficiency reviewing Module 4 and 5 datasets.
- Familiarity with global regulatory requirements/processes (e.g., EMA work sharing) and drug development.
- Familiarity with Veeva and other DMS/RIM systems.
- Ability to learn quickly, adapt, self-start, communicate clearly, troubleshoot, and maintain confidentiality.
Benefits (explicit):
- Health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Coordinate lifecycle submission requests for the global portfolio to ensure on-time, high-quality submissions meeting Health Authority (HA) and regional requirements.
- Partner with GBU and regional submission platforms to achieve/execute GSS plans and delivery using content re-use and technical expertise.
- Guide project teams on submission structure strategies in line with HA and ICH regulations/specifications.
- Support third-party vendors to improve submission efficiency.
- Prepare, compile, and review submission documentation for regulatory health authorities using ICH/eCTD and “submission-ready” standards.
- Ensure end-to-end process adherence for routine compliance submissions.
- Perform QC checks for submission publishing (validation criteria, troubleshooting).
- Support publishing process improvement and updates to quality documents.
- Identify and raise submission technical issues to enable timely resolutions ahead of filing dates.
- Maintain ongoing knowledge of regulatory requirements for document/submission assembly and publishing across regions.
Qualifications:
- Bachelor’s degree in regulatory affairs, sciences, or related area (other fields acceptable with publishing experience).
- 3+ years pharmaceutical industry experience with direct regulatory affairs experience.
- Proficiency in eCTD publishing tools/platforms.
- Knowledge of regulatory submission requirements for US, Canada, or EU.
- Dossier assembly and technical standards (eCTD structure/modules).
Preferred Skills:
- Working knowledge of drug laws/regulations/guidelines.
- Proficiency reviewing Module 4 and 5 datasets.
- Familiarity with global regulatory requirements/processes (e.g., EMA work sharing) and drug development.
- Familiarity with Veeva and other DMS/RIM systems.
- Ability to learn quickly, adapt, self-start, communicate clearly, troubleshoot, and maintain confidentiality.
Benefits (explicit):
- Health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.