Lead, R&D Document Standards & Integrated Services
Sanofi
June 29, 2026
Remote friendly (Morristown, NJ)
United States
$148,500 - $214,500 USD yearly
Operations
Responsibilities:
- Define and own long-term strategy for document standards, template governance, and submission-ready authoring across R&D.
- Standardize regulatory submission document preparation aligned to Health Authority requirements (NDA/MAA/IND/BLA/CTD).
- Establish and lead a governance/quality control model for templates (review cadence, approvals, access controls).
- Develop, version, and maintain Operational Procedures (OPEs) for template governance (GxP/regulatory-aligned).
- Optimize and harmonize template library; define template ownership and maintenance across Clinical, Nonclinical, PSPV, Regulatory, and CMC.
- Maintain a single source of truth for formatting standards; manage style assets with Digital.
- Lead cross-functional working groups and dashboards; implement submission readiness checklists/quality reviews.
- Partner to evaluate and implement authoring/submission technologies (incl. AI/automation, eCTD) and integrate standards into the R&D technology ecosystem.
- Lead change management, training, and communications; coordinate global stakeholder adoption and project milestone alignment.
Qualifications:
- BS or equivalent in regulatory affairs/sciences or related field (MS preferred).
- 8+ years in pharmaceutical document management or regulatory operations; process optimization, continuous improvement, and cross-functional leadership.
Required/Preferred Skills:
- EDMS, Adobe Acrobat, MS Office Suite, Veeva Vault RIM.
- Required: eCTD submission standards knowledge; regulatory information management systems valued.
- Strong written/verbal communication; analytical problem-solving; ability to manage priorities in a global matrix.
Benefits (if applicable):
- Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.
Languages:
- English proficiency required (verbal and written).
- Define and own long-term strategy for document standards, template governance, and submission-ready authoring across R&D.
- Standardize regulatory submission document preparation aligned to Health Authority requirements (NDA/MAA/IND/BLA/CTD).
- Establish and lead a governance/quality control model for templates (review cadence, approvals, access controls).
- Develop, version, and maintain Operational Procedures (OPEs) for template governance (GxP/regulatory-aligned).
- Optimize and harmonize template library; define template ownership and maintenance across Clinical, Nonclinical, PSPV, Regulatory, and CMC.
- Maintain a single source of truth for formatting standards; manage style assets with Digital.
- Lead cross-functional working groups and dashboards; implement submission readiness checklists/quality reviews.
- Partner to evaluate and implement authoring/submission technologies (incl. AI/automation, eCTD) and integrate standards into the R&D technology ecosystem.
- Lead change management, training, and communications; coordinate global stakeholder adoption and project milestone alignment.
Qualifications:
- BS or equivalent in regulatory affairs/sciences or related field (MS preferred).
- 8+ years in pharmaceutical document management or regulatory operations; process optimization, continuous improvement, and cross-functional leadership.
Required/Preferred Skills:
- EDMS, Adobe Acrobat, MS Office Suite, Veeva Vault RIM.
- Required: eCTD submission standards knowledge; regulatory information management systems valued.
- Strong written/verbal communication; analytical problem-solving; ability to manage priorities in a global matrix.
Benefits (if applicable):
- Health and wellbeing benefits; at least 14 weeks’ gender-neutral parental leave.
Languages:
- English proficiency required (verbal and written).