Regulatory CMC Policy Lead (M/W)

Servier; France; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Servier is seeking a Regulatory CMC policy lead to shape policy strategy and align internal teams across R&D, manufacturing and commercial functions. You will translate external regulatory signals into actionable internal alignment while strengthening cross-functional collaboration and external visibility.

With Servier's focus on oncology and neurology pipelines, the role involves representing Servier externally and contributing to the development of a forward-looking regulatory policy

Qualifications

• Pharmacist with advanced degree in biological sciences or equivalent.
• 5–10 years in regulatory CMC with policy-focused transversal responsibilities.
• Fluency in English with strong written and oral communication; French is a plus.

Responsabilités

• Monitor and analyse Regulatory CMC policy developments relevant to the business.
• Lead development of Regulatory CMC policy positions for implementation by technical teams.
• Inform and influence internal stakeholders towards strategically aligned regulatory solutions.
• Build external influencing strategy with trade associations and regulators to reflect Servier's position.
• Support policy tools and platforms to meet business needs.

Connaissances

Regulatory strategy

Policy mindset

Stakeholder influence

Formation

Pharmacist degree

Master's in Biological Sciences

Description du poste

The Regulatory CMC policy lead role is a new and unique opportunity for a policy mindset professional to join a growing team and to contribute to the successful expansion of the Servier portfolio.

The policy lead is expected to contribute to the scaling of the CMC Excellence function, supporting the development of a forward-looking and science-based policy capability that anticipates regulatory trends and enables consistent, strategic positioning across the organisation.

The role specifically acts as a connector, translating external regulatory signals into actionable internal alignment while strengthening cross-functional collaboration and external visibility.

With Servier heavily investing in its oncology and neurology pipelines, especially in the antisense oligonucleotide (ASO) and antibody drug conjugate (ADC) space, this is a unique and exciting role, where the successful candidate will also have responsibilities in representing Servier externally.

The role will report to the Head of CMC Excellence.

Main Responsibilities

• Proactively monitor, analyse and communicate Regulatory CMC policy developments, especially those of high interest to the business e.g. acceleration, platform technology, antibody drug conjugates, oligonucleotide, evolving ICH requirements…


• Lead the development of Regulatory CMC policy positions and work closely with the Regulatory CMC leads and CMC technical development and commercial manufacturing teams for the implementation of new technical and regulatory requirements or company initiatives.


• Inform and influence others towards strategically aligned solutions to address regulatory changes and/or complex issues that may impact Servier development programs and portfolio.


• Build and maintain an effective strategy for external influencing engagement including with trade associations, regulators and other relevant industry stakeholders to ensure Servier voice is reflected in future policies, regulations and guidance and to meet Servier objectives.


• Support the development and maintenance of the necessary policy tools and platforms that meet the business needs.

Detailed responsibilities

Contribute to the strengthening of the CMC Excellence function, by:

• Sharpening the ways of working, internal processes, and knowledge-sharing mechanisms and tools.


• Ensuring core deliverables on priority topics, e.g. position papers, 2-pager briefings.


• Driving early \"quick wins\" to demonstrate value added and build further credibility of the function.


• Monitor emerging global regulatory developments and scientific trends impacting CMC, especially by ICH, EMA, FDA, PMDA, NMPA and ANVISA.


• Synthesise complex information into clear, actionable insights and implications.

Cross-Functional Orchestration

• Contribute to building a strong internal network to anchor the function.


• Act as an interface across key stakeholders, e.g. Regulatory CMC, Regulatory Policy and Intelligence, Manufacturing, Quality, Supply Chain...


• Drive the identification of risks and opportunities on cross-functional topics e.g. ICH M4Q R2, and the development of relevant strategic plans.


• Ensure consistency and avoid duplication across initiatives and communications.

Contribution to External Positioning

• Support preparation of company positions and inputs to industry associations (e.g. EFPIA, BIO, IFPMA).


• Contribute to briefing documents and talking points for external engagement.


• Ensure internal stakeholders remain aligned with external advocacy strategies.

Communication & Enablement

• Drive internal awareness, and alignment across worldwide regulatory affairs and beyond on key policy topics through, e.g. development of 2-pager.


• Develop clear and concise communication materials e.g. executive briefs, presentations...


• Demonstrate ability to tailor messaging for different audiences, including senior leadership.

Profile :

• Pharmacist, masters degree in biological sciences or other relevant education;


• 5 to 10 years’ experience in the regulatory CMC space with significant experience in a similar policy role where transversal activities formed a significant part of the scope;


• Fluency in English with strong written and communication skills; additional languages including French, a plus.


• Excellent understanding of the industry and of pharmaceutical products development, registration and manufacturing;


• Developed knowledge of regulatory CMC requirements especially ICH, US FDA, Japan PMDA, China NMPA and EU EMA;


• Previous experience in working within the regulatory intelligence space, showing a strong policy mindset;


• Strong regulatory strategic skills and ability to influence stakeholders both internally and externally;


• Strong oral and written business communication skills with the ability to communicate complex issues across all levels of seniority in the company;


• Demonstrated ability to adapt quickly to meet evolving business priorities and expectations in a positive manner.


• Strong policy mindset with the ability to see the big picture and connect the dots in a complex environment;


• Strong interpersonal, collaboration and leadership skill;


• Well organized, scientifically driven, pragmatic and open;


• Excellent critical thinking and problem-solving skills.