Global Submission Associate
Sanofi
5 hours 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, ensuring on-time, high-quality submissions that meet Health Authority (HA) and regional requirements for 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 strategies in line with HA and ICH regulations, guidelines, and specifications.
- Collaborate with third-party vendors to support submission efficiency and overall success.
- Prepare, compile, and review regional submission documentation for regulatory health authorities per ICH/eCTD format and submission-ready standards, including Sanofi standards.
- Ensure end-to-end process adherence for routine compliance submissions.
- Perform QC checks for submission publishing, including validation criteria review and troubleshooting.
- Support continuous improvement of publishing processes and quality document updates.
- Identify and escalate submission technical issues in a timely manner to meet planned filing dates.
- Maintain ongoing knowledge of regulatory requirements for document/submission assembly and publishing across regions.
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/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.
- Proficiency in Module 4 and 5 dataset publishing and technical review.
- Understanding of global regulatory requirements and global submission processes (e.g., EMA work sharing).
- Familiarity with document management systems (e.g., Veeva), RIM systems, and DMS systems.
- Ability to learn/adapt quickly; self-starter mindset.
- Ability to implement/manage global regulatory technology solutions.
- Strong technical issue identification and troubleshooting; creative, achievable solutions.
- Strong attention to detail and accuracy.
- Excellent verbal and written communication across organizational levels.
- Ability to operate in a dynamic global environment; maintain confidentiality.
- Ability to collaborate across cultures and escalate issues to GRA leadership.
- Coordinate lifecycle submission requests for the global portfolio, ensuring on-time, high-quality submissions that meet Health Authority (HA) and regional requirements for 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 strategies in line with HA and ICH regulations, guidelines, and specifications.
- Collaborate with third-party vendors to support submission efficiency and overall success.
- Prepare, compile, and review regional submission documentation for regulatory health authorities per ICH/eCTD format and submission-ready standards, including Sanofi standards.
- Ensure end-to-end process adherence for routine compliance submissions.
- Perform QC checks for submission publishing, including validation criteria review and troubleshooting.
- Support continuous improvement of publishing processes and quality document updates.
- Identify and escalate submission technical issues in a timely manner to meet planned filing dates.
- Maintain ongoing knowledge of regulatory requirements for document/submission assembly and publishing across regions.
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/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.
- Proficiency in Module 4 and 5 dataset publishing and technical review.
- Understanding of global regulatory requirements and global submission processes (e.g., EMA work sharing).
- Familiarity with document management systems (e.g., Veeva), RIM systems, and DMS systems.
- Ability to learn/adapt quickly; self-starter mindset.
- Ability to implement/manage global regulatory technology solutions.
- Strong technical issue identification and troubleshooting; creative, achievable solutions.
- Strong attention to detail and accuracy.
- Excellent verbal and written communication across organizational levels.
- Ability to operate in a dynamic global environment; maintain confidentiality.
- Ability to collaborate across cultures and escalate issues to GRA leadership.