Regulatory CMC Policy Lead (M/W)

About the role

The Regulatory CMC Policy Lead role is a new and unique opportunity for a policy‑mindset professional to join a growing team and help expand Servier’s portfolio. The role will support the scaling of the CMC Excellence function by developing forward‑looking, science‑based policy capabilities that anticipate regulatory trends and enable consistent strategic positioning across the organisation.

Key responsibilities

• Monitor, analyse and communicate regulatory CMC policy developments, especially in acceleration, platform technologies, ADCs, oligonucleotides and evolving ICH requirements.
• Lead the creation of regulatory CMC policy positions and work with CMC technical development and commercial manufacturing teams to implement new technical and regulatory requirements.
• Influence internal stakeholders toward strategically aligned solutions addressing regulatory changes or complex issues impacting development programs.
• Build and maintain external influencing strategies with trade associations, regulators and industry stakeholders to ensure Servier’s voice is reflected in future policies.
• Support the development and maintenance of policy tools and platforms that meet business needs.
• Drive internal awareness and alignment worldwide through concise communication materials such as executive briefs and 2‑page briefings.

Required profile

• Pharmacist or master’s degree in biological sciences or a related field.
• 5–10 years of experience in regulatory CMC, with significant exposure to policy‑focused, transversal activities.
• Fluent English with strong written and verbal communication skills; French is a plus.
• Deep understanding of pharmaceutical product development, registration and manufacturing.
• Knowledge of regulatory CMC requirements across ICH, FDA, EMA, PMDA, NMPA.
• Proven ability to influence internal and external stakeholders and to adapt quickly to evolving business priorities.

Required skills

• Regulatory CMC expertise
• ICH guideline knowledge
• FDA regulatory requirements
• EMA regulatory framework
• PMDA (Japan) regulations
• NMPA (China) regulations