Regulatory Strategy & Continuous Improvement - Platform Lead

Job Title: Regulatory Strategy & Continuous Improvement - Platform Lead

Location: Morristown, NJ

As the Platform Lead within our R&D team, you will spearhead interconnected initiatives across the organization, coordinating multiple concurrent programs across global regulatory landscapes. You will establish global responsibilities across GRA CMC and GRA Device departments, build cross‑functional governance structures, identify synergies, and set metrics to drive continuous improvement. The role also involves facilitating cross‑project dependencies, developing communication strategies, synchronizing change management, and contributing to inspection readiness.

• Lead multiple interconnected and non‑interconnected initiatives involving diverse stakeholders.
• Orchestrate concurrent programs with varying timelines, priorities, and resources across global regulatory landscapes.
• Establish and maintain global responsibilities across GRA CMC & GRA Device departments, aligning project objectives with organizational strategy.
• Build and manage cross‑functional governance structures to facilitate decision‑making.
• Identify synergies between parallel projects to leverage shared resources and maximize efficiency.
• Set metrics and KPIs to track portfolio progress and drive continuous improvement.
• Facilitate resolution of cross‑project dependencies and conflicts through negotiation and prioritization.
• Develop communication strategies to maintain visibility of interdependencies across stakeholder groups.
• Synchronize change‑management processes across interconnected systems and procedures.
• Drive or manage transversal process‑related activities and deliver documents such as quality guides and slide kits.
• Contribute to harmonization and standardization of ways of working, optimizing change‑control and post‑approval processes.
• Validate, update, and consolidate the worldwide CMC post‑approval regulatory requirements database.
• Represent GRA CMC and/or GRA Device departments in transversal working groups focused on tools, systems optimization, and quality performance.
• Promote best practices and facilitate information sharing across departments to ensure alignment on critical CMC & Device topics.

• Education: Bachelor’s degree in a scientific discipline; advanced degree (MSc, Ph.D.) desirable.
• Experience: Minimum 4 years in CMC and/or Devices regulatory roles; additional 1–5 years of country/region‑specific expertise desirable.
• Project management experience required; experience in a regulatory authority, quality department, or manufacturing site preferred but not essential.
• Proven ability to work in a matrix environment with excellent people skills.
• Experience in fast‑paced environments managing multiple project lines.
• Strong organizational skills, flexibility, proactivity, initiative, and assertiveness.
• Potential to mentor and train staff (desirable).
• Knowledge of worldwide health authority regulations and regulatory trends.
• Strong background in project management and understanding of drug development, manufacture, or testing.
• Familiarity with combination (drug/device) products preferred.
• Proficiency in MS Word, Excel, PowerPoint.
• Fluent in English (spoken and written).

• Competitive salary range: $ – $ (commensurate with experience).
• Health benefits, prevention and wellness programs.
• At least 14 weeks’ gender‑neutral parental leave.
• Opportunity for global career advancement and lateral movement.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affidavit Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sexual orientation, disability, veteran or military status, or any other characteristic protected by law.