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Sanofi Group VACCINES - mRNA Global Regulatory Team Leader M/F in Marcy-l'Étoile, France

« Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. »

About the Opportunity

As an experienced mRNA Global Regulatory Team Leader, you will be in charge of the regulatory strategy for the mRNA vaccine.

In the race for the future of health – The Sanofi MRNA Center of Excellence

At Sanofi, we believe in a world in which no one suffers or dies from vaccine-preventable diseases. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines for more people faster than before.

That’s why we’re looking for bold, optimistic world-changers to support our mRNA Center of Excellence. We’re investing €400m a year into the new Center, hiring a team of 400 dedicated employees for it and using it as the foundation to implement integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

Bring your ambition and optimism for the future to Sanofi. Join us

JOB DESCRIPTION

A robust regulatory strategy, whether for transversal projects (e.g. New technologies) or for products (in development or marketed), is critical for the success of the business and for the company to meet its goals.

In addition, RA strategy has an impact on the access time to market.

GRTL role guarantee a worldwide regulatory strategy taken into account development needs and business needs. Interactions with Health Authorities is also key activity for the company in term of procedure management and about the image the company conveys.

The Global Regulatory Team Leader (GRTL) is part of the Global Regulatory Affairs (GRA) organization within the Sanofi Pasteur Global Business Unit (GBU)

  • He/she is accountable for developing long and short-term regulatory strategies for the projects and products under his/her accountability

  • The GRTL is accountable for the development as well as life cycle management strategies for the assigned project/products

  • The GRTL serves on cross-functional Global project teams and Global Brand Teams, representing Global Regulatory Affairs

  • The GRTL will lead the Global Regulatory Team (GRT ), comprised of several RA members such as Reg CMC, Reg Labelling, RA Regions and Reg OPS etc.

  • The GRTL develops the global product strategy , in collaboration with the GRT and is accountable for managing all the regulatory aspects of the product(s) throughout the life cycle of the product

  • The GRTL is accountable for the execution of the global product strategy, including prioritization of the global regulatory product activities

  • The GRTL provides the regulatory expertise necessary to develop global registration strategies for regional and local implementation

  • The GRTL is accountable for the global regulatory strategy development of Health Authorities interactions The GRTL will lead the regulatory contacts with External third parties and recommend the inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed

  • The GRTL may assist the Global Project Head and Global Brand Leader to manage joint venture company/companies during the vaccine development and license maintenance and/or territory expansion

  • The GRTL may lead a transversal regulatory project where all product-related activities justify several GRTLs

  • The GRTL is the main contact point between RA and non-RA function s (e.g. Clinical, GMA, PV, Non-Clinical, ComOps Franchise) for product related aspects

  • The GRTL is the GRA representative for Product Alert Teams/Crisis teams, as appropriate

  • The GRTL is responsible for presenting/defending their project/product regulatory strategies to key governance committees

  • The GRTL may participate in Due Diligence activities (In-licensing or Out-Licensing opportunities) to highlight the future potential for the asset from a regulatory standpoint, identifying regulatory risks associated with such opportunities and ways to mitigate them

MAJOR ACTIVITIES/KEY RESPONSIBILITIES

  • Represents GRA as a core member of the cross functional project team and Global Brand team and provides overall regulatory input for the project(s) globally. In this capacity, the GRTL is the single point of contact for the business on regulatory issues for the project(s)

  • The GRTL will ensure the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for their assigned products and will be accountable for developing and maintaining a global regulatory product strategy document (GRPS)

  • The GRTL will work transversally to ensure a properly functional Global Regulatory Team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries

  • The GRTL is responsible for prioritizing projects and activities with the GRT for lifecycle management activities (i.e. renewals, variations, new registration expansions)

  • The GRTL is accountable to present the global regulatory strategy/position to senior management / governance committees as needed

  • The GRTL will work with the GRT to develop and maintain the core dossier/Product Reference File

  • The GRTL will work with the labelling strategists and regional groups to ensure appropriate labelling content based on the clinical program and TPP. The GRTL will also work with the labelling strategist and regions to develop region specific labels

  • The GRTL will ensure timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed

  • Research and analyse regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes

  • Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate

  • The GRTL may line manage, and/or coach mentor, junior staff supporting the program

IDEAL BACKGROUND

Education (state preferred education and experience level)

  • PhD, Pharm D or DVM or MSc in Biology, Life Science, or related field of study; at least 5 to 8 years of prior Global Regulatory Affairs experience especially in development phase

  • Demonstrated knowledge of microbiology, immunology, virology or bacteriology

  • Experience in MRNA technology would be a plus

  • Experience working on Global Project Teams preferred

  • Proven record of successful registrations preferred

  • Ad-hoc management skills

EXPERIENCE/PROFESSIONAL REQUIREMENT

  • Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA, Health Canada, PMDA, Chinese HA etc.)

  • Strong strategic skills including the ability to make complex decisions and ability to defend difficult positions

  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance

  • Excellent coordination skills including planning, organizing and ability to motivate and lead others

  • Ability to work well within cross-functional teams and excellent transversal collaboration skills

  • Can demonstrate solid oral communication, presentation and writing skills

  • Understanding of the Global (including CA, US, EU, WHO, China, Japan in particular) and pharmaceutical marketplace and familiarity with medical terminology

  • Develops collaborative relationships to facilitate the accomplishment of work goals

  • Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities

  • Ability to take risks and to identify and manage them through mitigation and communication

  • Ability to operate outside his/her comfort zone

  • Shows ability to use appropriate interpersonal styles and techniques and can modify behaviour to gain acceptance of ideas or plans

  • Can build networks to obtain cooperation without relying on authority

  • Strong sensitivity for a multicultural/multinational environment

  • Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values

Languages

  • English fluent required (Other optional)

Please provide your resume in WORD or PDF format together with a motivation letter.

#MRNA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

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