Global Submission Associate
Sanofi
15 days ago
Remote friendly (Cambridge, MA)
United States
$75,000 - $108,333.33 USD yearly
Operations
Main Responsibilities
- Coordinate lifecycle submission requests for the global portfolio, ensuring on-time, high-quality submissions that meet Health Authority (HA) and regional requirements into global submissions.
- Partner with GBU and regional submission platforms to achieve and execute GSS plans and delivery using content re-use strategies and technical expertise.
- Guide project teams on submission structure strategy in line with HA and ICH regulations, guidelines, and specifications.
- Collaborate with third-party vendors to support submission efficiency and success.
- Prepare, compile, and review regional submission documentation for health authorities per ICH/eCTD format and submission-ready standards, as well as Sanofi standards.
- Ensure end-to-end process adherence for routine compliance submissions.
- Perform QC checks for submission publishing, including validation criteria, troubleshooting, and resolution of technical issues.
- Support publishing process improvements and updates to quality documents.
- Raise submission technical issues promptly to enable resolutions ahead of planned filing dates.
- Maintain ongoing knowledge of regulatory requirements for document and submission assembly/publishing across regions.
Qualifications
Basic Qualifications:
- Bachelor’s degree in regulatory affairs, sciences, or related areas (publishing experience considered for other fields).
- 3+ years pharmaceutical industry experience with direct regulatory affairs experience.
- Proficiency in eCTD publishing tools and platforms.
- Knowledge of regulatory submission requirements for US, Canada, or EU.
- Dossier assembly and technical standards (eCTD structure/modules).
Preferred Qualifications:
- Working knowledge of drug laws, regulations, and guidelines.
- Proficiency in publishing and technical review of Module 4 and 5 datasets.
- Familiarity with global regulatory requirements, global submission processes (e.g., EMA work sharing), and drug development.
- Experience with document management systems (e.g., Veeva) and RIM/DMS systems.
- Strong attention to detail/accuracy; excellent verbal and written communication; ability to learn quickly, adapt, work in dynamic global environments, maintain confidentiality, and collaborate/escalate.
Benefits
- Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Coordinate lifecycle submission requests for the global portfolio, ensuring on-time, high-quality submissions that meet Health Authority (HA) and regional requirements into global submissions.
- Partner with GBU and regional submission platforms to achieve and execute GSS plans and delivery using content re-use strategies and technical expertise.
- Guide project teams on submission structure strategy in line with HA and ICH regulations, guidelines, and specifications.
- Collaborate with third-party vendors to support submission efficiency and success.
- Prepare, compile, and review regional submission documentation for health authorities per ICH/eCTD format and submission-ready standards, as well as Sanofi standards.
- Ensure end-to-end process adherence for routine compliance submissions.
- Perform QC checks for submission publishing, including validation criteria, troubleshooting, and resolution of technical issues.
- Support publishing process improvements and updates to quality documents.
- Raise submission technical issues promptly to enable resolutions ahead of planned filing dates.
- Maintain ongoing knowledge of regulatory requirements for document and submission assembly/publishing across regions.
Qualifications
Basic Qualifications:
- Bachelor’s degree in regulatory affairs, sciences, or related areas (publishing experience considered for other fields).
- 3+ years pharmaceutical industry experience with direct regulatory affairs experience.
- Proficiency in eCTD publishing tools and platforms.
- Knowledge of regulatory submission requirements for US, Canada, or EU.
- Dossier assembly and technical standards (eCTD structure/modules).
Preferred Qualifications:
- Working knowledge of drug laws, regulations, and guidelines.
- Proficiency in publishing and technical review of Module 4 and 5 datasets.
- Familiarity with global regulatory requirements, global submission processes (e.g., EMA work sharing), and drug development.
- Experience with document management systems (e.g., Veeva) and RIM/DMS systems.
- Strong attention to detail/accuracy; excellent verbal and written communication; ability to learn quickly, adapt, work in dynamic global environments, maintain confidentiality, and collaborate/escalate.
Benefits
- Health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.