Lead, R&D Document Standards & Integrated Services
Sanofi
June 29, 2026
Remote friendly (Cambridge, MA)
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; standardize regulatory submission documents across NDA/MAA/IND/BLA/CTD.
- Establish governance/quality control for templates (review cadence, approval workflows, access controls); develop and maintain OPEs aligned with GxP/regulatory standards.
- Rationalize and harmonize document templates; maintain a single source of truth for formatting standards and visual style.
- Lead cross-functional working groups (Clinical, Nonclinical, Regulatory/Labeling, Quality, PSPV) and partner with Digital on style assets.
- Create/monitor dashboards; develop standardized preparation workflows and submission readiness checklists/quality reviews.
- Evaluate and implement tools/technologies for authoring and submission preparation (including AI/automation, eCTD); integrate document standards into the R&D technology ecosystem.
- Lead change management, training, and communications; coordinate global stakeholder adoption and alignment with submission timelines.
Qualifications
- Education: Bachelor’s degree (or equivalent) in regulatory affairs/sciences or related; Master’s preferred.
- Experience: 8+ years in pharmaceutical document management or regulatory operations; process optimization/continuous improvement and cross-functional leadership.
Skills/Requirements
- Proficiency with EDMS and tools (Adobe Acrobat, Microsoft Office, Veeva Vault RIM); eCTD standards required; regulatory information management valued.
- Strong written/verbal communication, analytical problem-solving, and ability to manage multiple priorities in matrix/global settings; adaptability.
- Demonstrated ability to identify process inefficiencies and propose practical solutions.
Benefits (if applicable per posting)
- Health and wellbeing benefits and at least 14 weeks’ gender-neutral parental leave.
- Define and own long-term strategy for document standards, template governance, and submission-ready authoring; standardize regulatory submission documents across NDA/MAA/IND/BLA/CTD.
- Establish governance/quality control for templates (review cadence, approval workflows, access controls); develop and maintain OPEs aligned with GxP/regulatory standards.
- Rationalize and harmonize document templates; maintain a single source of truth for formatting standards and visual style.
- Lead cross-functional working groups (Clinical, Nonclinical, Regulatory/Labeling, Quality, PSPV) and partner with Digital on style assets.
- Create/monitor dashboards; develop standardized preparation workflows and submission readiness checklists/quality reviews.
- Evaluate and implement tools/technologies for authoring and submission preparation (including AI/automation, eCTD); integrate document standards into the R&D technology ecosystem.
- Lead change management, training, and communications; coordinate global stakeholder adoption and alignment with submission timelines.
Qualifications
- Education: Bachelor’s degree (or equivalent) in regulatory affairs/sciences or related; Master’s preferred.
- Experience: 8+ years in pharmaceutical document management or regulatory operations; process optimization/continuous improvement and cross-functional leadership.
Skills/Requirements
- Proficiency with EDMS and tools (Adobe Acrobat, Microsoft Office, Veeva Vault RIM); eCTD standards required; regulatory information management valued.
- Strong written/verbal communication, analytical problem-solving, and ability to manage multiple priorities in matrix/global settings; adaptability.
- Demonstrated ability to identify process inefficiencies and propose practical solutions.
Benefits (if applicable per posting)
- Health and wellbeing benefits and at least 14 weeks’ gender-neutral parental leave.