Regulatory Site Section Head

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

About the job

Key dimensions - Scope & Scale:

Contributes to the adequate management of regulatory activities by supporting development and implementation of CMC related processes and tools on his/her perimeter.

Main responsibilities:

• Defining the potential regulatory impacts of changes made to the site products and services

• Managing the technical writing for the marketing applications of the site products; authoring the variations, the CTD sections impacted by the changes, the renewals of the site products registrations in compliance with all applicable regulations and company processes ·

• Ensuring compliance of the site products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates. Decide and execute the regulatory compliance maintenance program for the site products ·

• Providing the regulatory support during site inspections ·

• Maintaining a system to ensure regulatory risks are properly identified, tracked, and mitigated ·

• Monitoring the regulatory submissions and approvals for the site products and devices ·

• Monitoring and anticipating changes in the regulatory environment and determining the impact and implications for the site ·

• Developing and implementing regulatory procedures supporting the right operation of the activities ·

• Establishing metrics and monitoring data for the regulatory performance to identify trends and issues and to implement action plan ·

• Promoting a culture of quality throughout the site organization and ensuring a correct awareness of regulatory processes applicable to the site products

• Leading and managing the regulatory team, including hiring, training, coaching, professional development, and performance evaluation ·

• Managing the writing of the site master file

• Decide for which changes a regulatory strategy must be established and provide the information to site operations (D) ·

• Decide how to write CTD dossiers and responses to health authority queries (D) ·

• Decide and execute the regulatory compliance maintenance program for the site products (D) ·

• Review change’s regulatory strategy defined by GRA for the site products and devices (A) ·

• Provide the regulatory support during site inspections (A) ·

• Inform senior management on the action plan to mitigate regulatory issues (A) ·

• Proactively implement remediation action from findings from internal and external audits related to regulatory issues (I)

About you

• Education: Bachelor degree in Pharmaceutical Science, or Science

• Experience: 5 years of experience in regulatory affairs within the pharmaceutical industry, including preparation and submission of regulatory documents

• Skills:

• Communication & Presentation skills

• Computer skills - Sense of urgency & follow up skills

• Time management skills, High organization & planning skills

• Good Command of English Language

• Attention to Details

• Hard Worker and Team Worker

Technical Experience:

• In-depth understanding of regulatory requirements, guidelines, and processes within the pharmaceutical industry ·

• Strong project management skills to handle multiple regulatory projects and ensure timely submissions and compliance ·

• Excellent analytical skills to interpret regulatory changes, assess their impact, and develop appropriate strategies ·

• Effective communication skills to liaise with regulatory agencies, internal teams, and other stakeholders ·

• High level of attention to detail to ensure accuracy in regulatory documentation and compliance activities

Take the Lead Values

• Aim Higher: Focus on what matters, set high standards and move with urgency, learning from setbacks as we go to achieve higher performance.

• Act for Patients: Never compromise on integrity, eliminate barriers and partner with others to go faster and further for patients.

• Be Bold: Take thoughtful risks, seize opportunities and think beyond what's possible to accelerate our science and drive compelling growth.

• Lead Together: Build trust and collaborate openly on our shared goals, celebrate collective wins and foster a sense of belonging.